Professional Documents
Culture Documents
MyLab50 OperatorManuals E J
MyLab50 OperatorManuals E J
MyLab50 OperatorManuals E J
Rev. C
March 2007
MyLab50
INTRODUCTION
8300392000
User's kit
The box contains the licenses, the USB pen drive and the "Operator Manuals" disk.
Licenses
The licenses enable specific functions of the system, e.g. the Clip. Licenses are linked to
the system’s serial number and are, therefore, unique. They should be carefully stored.
The system is delivered by ESAOTE, with the licenses installed.
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Operator Manuals
These manuals refer to the MyLab50, MyLab50CV and MyLab50XVision products, indicated
by the name MyLab inside the manuals. The Operator Manuals consist of three Sections:
Getting Started
The manual describes how to install the system and provides the main instructions for
using it.
3/12
MANUFACTURER’S RESPONSIBILITY
ESAOTE is responsible for the safety, reliability and functioning of this product only if:
• the user follows all the instructions contained in this Manual for the use and the
maintenance of this system;
• this Manual is kept integral and readable in all its parts;
• calibrations, modifications and repairing are performed only by ESAOTE
qualified personnel;
• the environment where the system is used complies with the current safety rules;
• the electrical plant of the environment where the system is used complies with the
current applicable rules and is perfectly efficient.
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Product Life Cycle
Life Time
The safety and effectiveness of MyLab ultrasound systems are guaranteed for at least
ten years from the purchase date, provided that:
• the system is used in accordance with the instructions given in the User Manual
(and its eventual Addenda), which must be always accessible to the whole
personnel in an integral and readable status;
• any installation, maintenance, calibration, modification and repairing operation is
performed on the system only by ESAOTE qualified personnel, using original
ESAOTE spare parts.
When approaching the ten years limit from the purchase date, it is recommended to
contact ESAOTE Service ot to visit ESAOTE web site (www.esaote.com), to get
updated information on the product’s end of life and/or to agree on the most suitable
solution for its safe disposal.
Maintainability Time
Esaote S.p.A. ensures maintanability of MyLab ultrasound systems for ten years from
the purchase date.
End-of-Life Disposal
MyLab ultrasound systems fall within the application field of the 2002/96/EC
Directive on waste electrical and electronic equipment (WEEE).
The main system plate includes therefore the symbol shown below, indicating - in an
unequivocal way – that the system must be disposed of in a separate collection from
urban waste and that it was introduced in the market after August 13th, 2005.
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When disposing of any system part, the user shall consider the following points:
• any recyclable part of the system and/or of its packaging is labelled with the
corresponding symbol;
• all components used for the packaging are recyclable and/or reusable, except the
closed-coupled barriers.
Caution
The system and its comsumable parts must be disposed of, at end of life, according to
the applicable state and/or federal and/or local regulations.
6/12
DICHIARAZIONE CE DI CONFORMITA’ - Direttiva 93/42/CEE - allegato II
CE DECLARATION OF CONFORMITY - 93/42/EEC Directive - annex II
DECLARATION DE CONFORMITÉ - 93/42/CEE - annexe II
KONFORMITÄTSERKLÄRUNG - 93/42/EWG - Anhang II
DECLARACIÓN DE CONFORMIDAD CE - Directiva 93/42/EEC
Noi costruttori:
We manufacturer:
Nous les Constructeurs:
Wir, die Hersteller:
Nosotros, los fabricantes
MyLab50
MyLab50CV
MyLab50XVision
mit der Anwendung des geprüften Qualitätssystems für das Projekt, die Fertigung
und die Schlußkontrolle des Produkts gefertigt wurde und daß es die Anordnungen
der Richtlinie 93/42/EWG-Anhang II für medizinische Geräte erfüllt.
7/12
USAGE LICENSE AGREEMENT FOR THE SOFTWARE INCLUDED IN
THE APPARATUS
Attention
Please read with care the terms and conditions indicated below before using
the software on the unit.
Use of the software implies acceptance of the terms and conditions listed
below.
PROPRIETARY RIGHTS
You have acquired a device (“DEVICE”) which includes Esaote S.p.A. proprietary
software and/or software licensed by Esaote S.p.A. from one or more software licensors
(“Software Suppliers”). Such software products (“SOFTWARE”), as well as associated
media, printed materials, and “online” or electronic documentation are protected by
international intellectual property laws and treaties. The SOFTWARE is licensed, not sold.
The SOFTWARE and, similarly, any copyrights and all industrial and intellectual
ownership rights are and shall remain the exclusive propriety of Esaote S.p.A. or its
Software Suppliers.
The user will acquire no title or right on the SOFTWARE, except for the usage license
granted herein.
8/12
PRODUCT TRACEABILITY
To guarantee the product traceability according to what stated by the quality standard
ISO13485 and by the European Directive on Medical Devices 93/42/EEC, ESAOTE kindly
requests the original owner of the equipment to give communication to our central plants, or
to one of our subsidiaries, or to one of our official distributors of any eventual conveyance of
the product property. Please use a duly filled copy of the form reported below or send us a
communication reporting the same data indicated in this form. All data relating to the system
can be found on its identification label.
Signature
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VIGILANCE SYSTEM
This equipment is subject to ESAOTE vigilance system (post-marketing vigilance) in case of
potential or real hazards for the patient or for the operator which might occur during the
normal system functioning, in order to be able to remove them with the best efficiency and
timing.
Therefore if the user records any malfunction or deterioration in the characteristics and/or
performances of the device, as well as any inadequacy in the labelling or the instructions for
use which might lead to potential or real hazards for a patient or for an operator, we kindly
request to immediately inform ESAOTE central plants, or one of our subsidiaries, or one of
our official distributors immediately through the following form, or through a
communication reporting the same data contained in this form. All data relating to the system
can be found on its identification label. In this way we will be able to take all adequate
measures with the best efficiency and timing.
Signature
10/12
Important Information
This mark complies with the Medical Device Directive
93/42/EEC.
For US Customers: US Federal Law restricts this device to sale, distribution and
use by or on the order of a physician.
11/12
12/12
ESAOTE S.p.A.
Rev. F
July 2007
MyLab50
GETTING STARTED
8300391000
GETTING STARTED
GETTING STARTED
Introduction
This manual refers to the MyLab50, MyLab50CV and MyLab50XVision ultrasound
systems, named in the following chapters as MyLab. The term “MyLab”, used in this
manual, refers to all configurations. When the information refers to only one
configuration, it will be specifically indicated.
This manual explains how to install and use the MyLab ultrasound systems. All
system keys and their functions are described. Whether these keys are enabled or
disabled depends on the installed software and its release.
In this manual control panel keys and software keys are indicated using the following
graphical conventions:
Control panel keys They are indicated by BLUE CAPITAL LETTERS or by the
corresponding graphic symbol (e.g. ).
The confirmation key is always indicated throughout the manual as ENTER, while the
menu context key as UNDO.
Table of Contents
i
Configuration Menu......................................................................................................................9-1
General Preset ...............................................................................................................................9-1
Application Preset .........................................................................................................................9-2
User Preset ....................................................................................................................................9-2
Tools Preset...................................................................................................................................9-3
Report Customization ...................................................................................................................9-3
Application Measurements ...........................................................................................................9-4
Generic Measurements..................................................................................................................9-4
Glossary ........................................................................................................................................9-4
Peripherals.....................................................................................................................................9-4
Network Drives Configuration......................................................................................................9-4
Dicom Configuration ....................................................................................................................9-5
Save & Load Presets .....................................................................................................................9-5
Security .........................................................................................................................................9-5
Service...........................................................................................................................................9-5
System Configuration ...................................................................................................................9-5
Licenses.........................................................................................................................................9-5
Shut Down ....................................................................................................................................9-5
10 - System Maintenance .........................................................................................................10-1
Cleaning of System and Peripheral Units ...................................................................................10-1
11 - Technical Specifications ..................................................................................................11-1
MyLab50 Configuration .............................................................................................................11-1
MyLab50CV Configuration........................................................................................................11-2
MyLab50XVsion Configuration .................................................................................................11-3
MyLab Technical Specifications ................................................................................................11-4
Safety Standards..........................................................................................................................11-6
Probes..........................................................................................................................................11-7
System Accessories.....................................................................................................................11-8
Video Requirements....................................................................................................................11-8
Appendix A - Acoustic Output Tables .....................................................................................A-1
Acoustic Output Data according to FDA.....................................................................................A-1
Acoustic Output Data according to IEC61157 ........................................................................A-169
ii
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M y L a b 5 0 – G E T T I N G S T A R T E D
Chapter
1 - Additional Information on
Safety
This chapter provides additional information on safety specifically for MyLab.
SS Please read the "Safety and Standards" manual carefully for a complete overview of
all safety aspects of MyLab.
Environmental Safety
Special waste These systems contain a lithium battery. The battery must be treated as special
waste in conformity with applicable local regulations.
Transport Safety
The system front wheels are equipped with brakes, which can be activated
individually.
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M y L a b 5 0 – G E T T I N G S T A R T E D
Electromagnetic Compatibility
This system was designed for use in the electromagnetic environments declared in
the tables below, in compliance with standard IEC 60601-1-2:2001. The operator
must make sure that s/he uses it in keeping with this standard.
Electromagnetic Emissions
Emission Test Conformity Electromagnetic Environment
Electromagnetic Immunity
The electromagnetic tests are aimed at simulating the typical transients of an
electromagnetic environment. MyLab was tested for immunity to transients and at
their typical levels in a domestic, hospital or commercial environment.
±2 kV common
mode
1-2
M y L a b 5 0 – G E T T I N G S T A R T E D
1-3
M y L a b 5 0 – G E T T I N G S T A R T E D
1-4
2
M y L a b 5 0 – G E T T I N G S T A R T E D
Chapter
2 - Clinical Applications
MyLab is designed for operators who are qualified in using ultrasound systems.
Configurations
When fully configured, the system offers a variety of intended uses.
SS Note
Carefully read
Chapter 2 of the
"Safety and The operator must always follow the principle known as ALARA (As
Standards" manual. Low As Reasonably Achievable) and must use minimum acoustic
power for the minimum time required to obtain diagnostic
information
Basic Configuration
MyLab50 MyLab50 can be configured with one or more of the following applications:
Application Notes
Cardiac (CAR) Includes transesophageal exams if a TEE022 (for
cardiology in adults) and/or a TEE122 (pediatric
cardiology) is available
Vascular (PV) Includes ADULT CEPHALIC application
General Imaging Includes ABDOMEN (ABD), PEDIATRIC, BREAST,
THYROID, other SMALL PARTS (testicles,…) and
MUSCULO-SKELETAL (MS); includes endovaginal and
transrectal exams if an endocavity probe is available
Breast (SP) -
Thyroid (SP) -
Musculo-Skeletal (MS) -
Urology (UR) -
Obstetrics (OB-GYN) Includes gynecologic application
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M y L a b 5 0 – G E T T I N G S T A R T E D
MyLab50XVsion MyLab50XVision can be configured with one or more of the following applications:
Application Notes
Cardiac (CAR) Includes transesophageal exams if a TEE022 (cardiology
in adults) or a TEE122 (pediatric cardiology) is available
Vascular (PV) Includes ADULT CEPHALIC application
General Imaging Includes ABDOMEN (ABD), PEDIATRIC, BREAST,
THYROID, other SMALL PARTS (testicles,…) and
MUSCULO-SKELETAL (MS); includes endovaginal and
transrectal exams if an endocavity probe is available
Breast (SP) -
Thyroid (SP) -
Musculo-Skeletal (MS) -
Urology (UR) -
Obstetrics (OB-GYN) Includes gynecologic application
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M y L a b 5 0 – G E T T I N G S T A R T E D
Do not use intraoperative and laparoscopic probes in direct contact with the
heart, the central circulatory system and the central nervous system
Cardiac Applications
The probe applies ultrasound energy through the thoracic cavity to obtain an
image of the heart sufficient for evaluating any cardiac abnormalities. In Doppler
modes, the probe applies energy through the thoracic cavity to determine the
velocity and direction of blood in the heart and vessels.
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M y L a b 5 0 – G E T T I N G S T A R T E D
The heart can also be studied through the esophagus and/or transgastrically with a
transesophageal probe (TEE022 in adults, TEE122 in pediatric cardiology).
Pediatric Applications
The probe applies ultrasound energy through the skin in order to obtain images
and evaluate flows in pediatric and neonatal exams. In the latter case, the probe
applies ultrasound energy through the fontanel in order to visualize cerebral
structures (Imaging) or flows (Doppler) to detect structural or functional
abnormalities.
SS Note
Carefully read
Chapter 2 of the
"Safety and The operator must always follow the principle known as ALARA (As
Standards" manual. Low As Reasonably Achievable) and, in particular with this
application, must use minimum acoustic power for the minimum
time compatible with obtaining diagnostic information.
Vascular Applications
The probe applies ultrasound energy through the neck or the limbs of a patient in
order to obtain an image of the carotid artery or of other peripheral vessels. These
images show the possible presence of abnormalities or obstructions of the vessels.
In Doppler modes, the probe applies ultrasound energy through the neck or the
hands/feet of a patient in order to evaluate blood velocity, flow or lack of flow,
and the perviousness of the peripheral vessels.
SS Note
Carefully read
Chapter 2 of the
"Safety and The operator must always follow the principle known as ALARA (As
Standards" manual. Low As Reasonably Achievable) and, in particular with this
application, must use minimum acoustic power for the minimum
time compatible with obtaining diagnostic information.
2-4
M y L a b 5 0 – G E T T I N G S T A R T E D
Musculo-Skeletal
The probe applies ultrasound energy through the skin to obtain an image of
tendons, ligaments and muscles and to determine blood flow patterns and
velocities.
Adult Cephalic
The probe applies ultrasound energy through the skull in order to visualize cerbral
vessels and flows, to detect funtional abnormalities.
Abdominal applications
The probe applies ultrasound energy through the patient abdomen to obtain an
image of the abdominal organs to detect abnormalities (Imaging) and assess the
blood velocity, flow and patency of abdominal vessels through the Doppler
modalities. In gynaecology and urology, ultrasound energy is applied through the
skin to image the female genito-urinary organs or the kidney and males genito-
urinary structures (prostate, bladder,…). An endocavity probe can also be used to
image the same organs, either endovaginally (gynaecologic application) or
transrectally (urologic application).
OB Application
The probe applies ultrasound energy through a pregnant woman’s abdomen to
obtain an image of the fetus to detect structural abnormalities or to visualize and
measure anatomic and physiologic parameters of the fetus for the purpose of
assessing fetal growth. In Doppler modes, the probe applies energy through the
patient abdomen to detect placental or fetal flow abnormalities. An endocavity
probe can also be used for the same purposes (endovaginal studies).
SS Note
Carefully read
Chapter 2 of the
"Safety and The user should always follow the ALARA (As Low As Reasonably
Standards" manual. Achievable) principle, but especially in OB/fetal applications. Use the
lowest amount of acoustic output power for the shortest duration of
time to obtain the necessary clinical diagnostic information.
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M y L a b 5 0 – G E T T I N G S T A R T E D
2-6
3
M y L a b 5 0 - G E T T I N G S T A R T E D
Chapter
System Overview
The MyLab50 XVision model is equipped with a tiltable 19” LCD, the MyLab50
and MyLab50CV model with a tiltable 17” monitor.
3-1
M y L a b 5 0 - G E T T I N G S T A R T E D
The control panel assembly can be rotated for optimal orientation for the operator
and for transportation.
Console
Probe Connectors Probes connectors are located on the front of the system (right side); three imaging
and one Doppler probe connectors are available.
USB Ports Two USB ports are located on the front of the system (left side); these ports can
be used to connect a USB printer or a USB pen key for digital data storage.
Power Plug The power cord plug, the fuse box and the electrical power switch (mains switch)
are located on the bottom of the system, at the rear.
Wheels The posterior wheels are permanently fixed; anterior wheels are rotational. Each
anterior wheel has two levers to lock (grey to brake and green to lock the rotational
mechanism) and one on top to release.
Peripherals
Housing
The console top is equipped to house
two video peripherals (for example a
printer and a VTR); peripherals can
be easily connected and disconnected
via the pre-installed cables (shown in
the drawing at the left) and secured
to the system console with belts.
3-2
M y L a b 5 0 - G E T T I N G S T A R T E D
Rear Panel
C1 C2 C3 C4 C5 C6 C7 C8 C11
C9 C10
AUX
2 1 SYNC R G B
!
!
Others When included as part of the configuration, the ECG cable (C28) and an RJ45
LAN cable (C2) exit from the bottom rear of the console at the rear, along with the
auxiliary foot-switch.
The ECG cable is wired to generate a I lead trace. By suitably positioning the
electrodes, the operator can obtain a II or III lead trace.
Never disconnect the probe while it is active. Press the FREEZE key before
C A U T I O N
disconnecting the probe.
3-3
M y L a b 5 0 - G E T T I N G S T A R T E D
Video Peripheral Before installing the peripheral units, make sure that the system is switched off and
Units unplug the power cable from the mains. Lock the trolley by engaging the brakes.
The "Safety and Standards" manual provides the safety requirements and standards
SS to be observed for using peripheral units with your system.
Open the console top cover to access the peripherals pre-installed cables; plug a
free power cable into the peripheral mains socket.
Contact ESAOTE Connect the video signals as appropriate: pre-installed cables are clearly labeled to
personnel for guide the connection. Each cable is labeled, at the connector end, with a
recommended video
peripherals
description of its destination port (example: C-VIDEO IN ).
compatible with the
system. Replace the console cover; fit the video device into its desired position and secure
it with the belts.
Note
USB Printers The system can be connected to USB printers via a USB Port.
Contact ESAOTE personnel for recommended USB printers and for safe and
proper installation.
3-4
M y L a b 5 0 - G E T T I N G S T A R T E D
These two rotations are controlled by locks located below the control panel and by
a device located on its side (as shown in the drawings below).
Acclimation Time
If the system has been exposed to temperatures which are outside the range given
for its correct working (15÷35°C), it must acclimate, before being switched on. The
following table indicates the necessary waiting times:.
T(°C) 60 55 50 45 40 35÷15 10
Hours 8 6 4 2 1 0 1
T(°C) 5 0 -5 -10 -15 -20
Hours 2 4 6 8 10 12
3-5
M y L a b 5 0 - G E T T I N G S T A R T E D
The monitor or the The control panel orientation and lifting devices can now be used to optimally
LCD can be directly adjust the control panel and the screen working position. Push the orientation lever
rotated or tilted
independently from
to unlock and rotate the control panel into the new position. Release the lock when
the control panel the control panel is correctly positioned. To lift or let down the keyboard, unlock
the lever, by pushing it towards left, and operating on the handle, place the
keyboard on the desired height.
Plug the power cord into the mains; turn on the rear panel mains switch. The
ON/OFF control panel button may then be used to power the system on and off.
Note
• If the probes are connected, be sure that they are properly placed in the
suitable MyLab probe-carriers and that the cables do not reach the floor.
• The wheels of MyLab are provided with brakes; be sure the brakes are
disabled before moving the ultrasound apparatus.
• Avoid any unnecessary mechanical shocks to the system while moving it.
Only the handles on the keyboard must be used for moving the system and
W A R N I N G
rotate the keyboard.
Make sure not to damage the peripherals placed on the console when
rotating the keyboard.
3-6
M y L a b 5 0 - G E T T I N G S T A R T E D
Make sure that the probes are locked in the appropriate holders and the
probe cables are properly hanged in the cable hooks during the movement
of the system.
The handles on the keyboard cannot be used for lifting the system.
For locking the system in a stable way is necessary to lock at least two
wheels.
Transportation When transporting the system by vehicle, remind to:
3-7
M y L a b 5 0 - G E T T I N G S T A R T E D
3-8
4
M y L a b 5 0 – G E T T I N G S T A R T E D
Chapter
4 - Control Panel
This chapter provides a brief description of the system controls.
Alphanumeric Section
This section includes the ON/OFF button, TGC controls and an alphanumeric
keyboard.
The ON/OFF button turns the system on and off; this button is operable only if
the rear panel mains switch is ON.
This is a PC based system; data loss or driver damage may occur if the
C A U T I O N
system is turned off while working. Refer to appropriate sections of this
manual for detailed information on when and how to safely power the
system off.
4-1
M y L a b 5 0 – G E T T I N G S T A R T E D
The yShift key is used for typing in lower case or upper case characters (according
to how the keyboard is set) or the characters indicated in the top left section of
some keys.
Special Characters With MyLab, the operator can type in the special characters through the
Windows® XP standard modalities. To type in special characters, two keys have to
be simultaneously pressed. The table below: shows the operating modalities.
‘ (Apostrophe) e, y, u, i, o, a, c é, ý, ú, í, ó, á, ç
` (Grave accent) e, u, i, o, a è, ù, ì, ò, à
^ (Circumflex) e, u, i, o, a ê, û, î, ô, â
~ (Tilde) o, a, n õ, ã, ñ
“ (Diaeresis) e, y, u, i, o, a, ë, ÿ, ü, ï, ö, ä
The following characters are also available, if the operator presses the Alt key and
the numbers sequence listed in the table below:
0229 å
0230 æ
0248 ø
0223 ß
Text Entry If any of the alphanumeric keys are pressed during the exam, this automatically
activates the input of text. All writing operations are managed by the alphanumeric
AO keyboard and trackball, the trackball is used to position the cursor.
The key allows to access a glossary, which can be configured by the user.
Refer to the “Advanced Operation” manual for more information on text entry.
Trackball
The trackball operates in two different modes.
Standard Mode In its standard function, the trackball allows quickly positioning of the cursors on
the screen. The following chapters provide details of the specific functions
performed by the trackball.
4-2
M y L a b 5 0 – G E T T I N G S T A R T E D
Mode Trackball
B-Mode Transmission focal point
M-Mode, Doppler LINE cursor
CFM CFM ROI cursor
ACTION key If the screen contains several cursors, the ACTION key activates the active cursor.
Mouse Mode The trackball can then be used to move a pointer on the screen. In Real-Time the
pointer can be used to activate software keys functions and to toggle through their
AO menus. In Freeze, Exam review and Archive review the pointer can be used to
Refer to “System
Configuration” section for access archive menus. In this case, the keys placed on the left and right side of the
trackball configuration trackball can be set as mouse keys (as enter and context menu keys).
Regardless of the trackball configuration, the enter and context menu keys are
respectively indicated as ENTER and UNDO keys in this manual.
The POINTER key enables the user to change the trackball operation from standard
to mouse mode.
Software Keys
Four buttons and six menu toggles are located at the bottom of the monitor (as
shown in the drawing).
The functions of these keys vary according to mode, application, and settings. The
menu shown above the keys indicates the functions assigned to them.
4-3
M y L a b 5 0 – G E T T I N G S T A R T E D
• If the displayed menu has more than six scrolling toggles, the sixth
toggle (NEXT/PREVIOUS) is used to scroll through the menus of the first
five keys. Press the push-buttons to select the required setting.
Controls Section
Exam Flow
START END is the key that opens and closes every exam. The menu is used for
entering patient data and for the choice of application, probe and required presets.
During the exam, the user may select a different probe (key ) or preset (key
).
When the exam is finished, press the START END key again. It is then possible to
archive the patient's data and produce an exam report. The system clears the stored
data and shows the exam start window again.
The PATIENT ID key is used to input or modify the patient's data during the exam.
AO
The Mode Keys
The B key re-activates a B-Mode image in Real-Time when the system is used in
any other mode. If pressed in M-Mode, Doppler or Freeze, the B key restores a full
screen bi-dimensional image.
The Color Doppler Mode (CFM) is activated or disabled by pressing the CFM key
in B- or M-Mode.
In B-Mode, a cursor delimits the Region of Interest (ROI) where color analysis is
executed and displayed. The ROI's dimensions and position can be allowed with
the trackball, activating the ROI cursor with the ACTION key.
The Real-Time Soft Keys menu allows the operator to alter the display mode and
to switch to Power Color or TVM (Tissue Velocity Mapping). TVM1 utilizes
Doppler to display the heart walls motion, rather than flow.
The displayed menu enables to alter the B-Mode and make it coincide with the
ROI ("Coincident" view).
Color M-Mode is shown via full screen or with a reference 2D, according to the
choices on the displayed menu.
The M key activates the M-Mode, and if necessary, the selection cursor (B-Line).
There are five possible viewing formats: full screen format in M-Mode; dual
format, with the screen split vertically with 2D on the left and the trace on the
1TVM and TV modes are enabled only with the PA230, PA122, TE022 and TE122 probes in a cardiac
application.
4-4
M y L a b 5 0 – G E T T I N G S T A R T E D
right; the split screen formats, with the screen split horizontally, with the reference
2D above (out of three possible dimensions) and the M-Mode trace below. The
viewing format can be preset and varied in Real-Time through the displayed menu.
The PW key is used for activating the Pulsed Wave Doppler (PW), CW for
activating the Continuous Wave Doppler (CW); both keys activate the positioning
cursor. As in M-Mode, there are five viewing formats: the three split formats, the
dual format and the full screen format. In PW, the Real-Time Soft Keys menu
allows the operator to switch to TV1 (Tissue Velocity) display mode. TV sets
Doppler filters to display strong signals with low motion such as the heart walls
motion, rather than flow.
During the exam, the format can be preset or altered interactively through the use
of the menu.
In 2D or CFM, the line cursor (LINE key) can be interactively activated or disabled
to select the M-Mode or Doppler Mode.
In both M-Mode and Doppler, the UPDATE key begins the trace acquisition. If this
key is pressed during acquisition, the trace is frozen and the reference 2D is
temporarily re-activated.
If during the exam some preset parameters are changed, the key allows to
restore the parameters configured for the active application.
The key stops the current analysis or scan and puts the system in Freeze
mode. To re-activate in Real-Time, press a second time or directly press the
applicable key for the required mode.
Format Controls
According to how the system is preset or to the selections on the displayed menu,
these keys activate multiple views of two (dual) or four 2D (quad) images. In Dual
mode, the user can display two different images or the same 2D/2D-CFM image
simultaneously.
The Zoom function, active both in Real-Time and in Freeze, is used to selectively
enlarge a region of the image in B-Mode or in CFM.
Initial pressing of the ZOOM key activates a sectorial cursor that can be positioned
(and possibly varied in terms of dimensions) by the trackball on the region of
interest. The second pressure activates the enlarged presentation of the selected
region. Press ZOOM to return to a normal format.
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M y L a b 5 0 – G E T T I N G S T A R T E D
Use the UNDO key to cancel the enlargement factor cursor from the as yet non-
enlarged image.
Basic Controls
Gain Knobs The B/M and Doppler knobs are used for adjusting the amplification of the echo
signal. Gain is increased by turning the Gain knob clockwise and is reduced by
turning the Gain knob counter- clockwise.
The B/M knob on the right affects on the B- and M-Mode signals, adjusting
amplification over the entire depth of the image. The Doppler knob amplifies the
CFM and Doppler gain, according to which mode is active. In Doppler mode, gain
affects both components of the signal (video and audio). The level of the audio
signal may be independently adjusted with the AUDIO knob, which is disabled in the
imaging modes.
If some preset parameters are altered during the exam, the key can be used to
restore the presets set for the active application.
The DEPTH knob increases or reduces scanning depth in all imaging modes.
When the cursor is active, the DEPTH key varies the dimension of the area to
be enlarged.
The POWER knob is active in Real-Time only and is used for varying emitted
power during the exam. It operates independently for each mode: e.g. in PW
mode, it controls the power of the Pulsed Wave Doppler; in 2D-CFM mode, it
controls the power of the CFM.
In all applications where the ECG is shown, the key enables the operator to
vary the amplitude of the ECG trace and its position selection on the screen.
Exam Storage
During the exam, the operator can save both individual images and sequences (for
systems having the clip license) by using the IMAGE key, for the frames, and CLIP
key, for the sequences (2D or CFM). The stored images and sequences are
displayed as thumbnails on the right side of the screen.
The key is used for accessing, at any time, the data stored during the current
exam. To access the data archive, press the key.
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M y L a b 5 0 – G E T T I N G S T A R T E D
Exam Report
General measurements ( key) and access to the calculations package may
always be executed, specifically for the application in progress (MEASURE key).
When the required key is pressed, the list of available measurements is shown to
the right of the image.
Peripherals Management
The keyboard can control two different peripheral units with keys 1 and 2,
according to the system's presets. For example, the operator can connect both a
B/W printer and an RGB printer and control them separately with these keys.
This key activates and disables the VTR Menu. The software keys menu enables
video recorder play-back and other VTR operations (fast forward, eject,....).
Note
Settings
The MENU key displays the system menu for all configurations / settings (center
name, preset…). The menu is explained in detail in a following chapter.
Advanced Operations
Keys MARK, REPORT, ANNOT, ACQUIRE and CONTRAST activate advanced
AO operations: further details on how to use them are described in the "Advanced
Operations" manual.
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4-8
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Chapter
5 - Screen Lay-Out
This chapter provides a brief description of the information on the MyLab screen.
Heading
This area is used for displaying the icons for the following: trackball, archival
systems, configured peripheral units; it also displays the following information:
center and patient data, and the date.
For setting center Patient data is displayed only if entered at the beginning of the exam. The system
data, see the Chapter displays the following patient data: last name and first name, age and patient code.
9 of this manual.
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Trackball
The trackball function is indicated by the icon shown at the top left side of the
screen.
When there are several cursors on the screen, two icons are displayed
simultaneously. The yellow icon shown on the left indicates the active cursor; the
green cursor on the right indicates the next cursor that can be activated. The
ACTION key switches between the cursors.
Archival Systems
The archival system icons are shown at top left of the screen, after the trackball
icons. The icon is blinking and bordered in yellow while working; it is shown
crossed out whenever there are management problems involving the specific
archival system.
For more details on data archival, consult the Chapter 8 and the Advanced
AO Operations manual.
Peripheral Units
The system is able to simultaneously manage two peripheral units (b/w or RGB
printer and the VTR). The icons of the peripheral units are shown at top right of
the screen.
If no peripheral unit is enabled, the right side of the header bar shows two gray
icons.
The peripheral units’ icon is shown crossed out whenever there are management
problems involving the specific peripheral unit.
Whenever an image is frozen, a memory bar is displayed (at the bottom right of the
screen) and indicates the scrolling memories. The images acquired immediately
before the system is put into freeze mode and archived in the scrolling memories
area. The trackball can be used to examine the 2D, M-Mode, Doppler and CFM
information image image–by-image.
Image Area
The display of the image depends on various factors such as active mode, selected
application, and transducer. The following screen shot shows the elements in the
image area which are independent of the factors listed above.
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Legenda:
Number Icon
1 Active application
2 Machine parameters
3 Sector orientation
4 Acoustic output data
5 Thumbnails of stored images
6 Focal zone
7 If colored, it indicates images to be scrolled
8 Frame Rate
9 Heart rate
10 CFM scale
11 Imaging scale
12 Active probe
13 Selected preset
Applications
The system displays different icons according to the selected application.
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Machine Parameters
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Chapter
6 - Exam Performance
This chapter describes the operations typically performed while an exam is being
performed and how to turn the system off at the end of the session.
Read the Safety and Standards Manual carefully: all the safety
SS characteristics, cautions and warnings listed apply to all exams.
Do not turn the system off during the initialization phase: the hard disk
C A U T I O N
could be damaged by this operation.
In the Exam Start window the operator can enter patient data, select the
application, as well as the required presets and probe.
Note
AO To guarantee data integrity and confidentiality, the system allows to
configure a list of users allowed to work on the system. In this case
to access the system the user needs to log in and type a password. See
the “Advanced Operations” manual for further information.
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Age is automatically
calculated from the
date of birth. In
cardiac applications
one can enter height,
weight and BSA
values.
Note
The user may program and add presets to better suit individual
clinical needs or preferences, while applications depend on the
installed optional licenses.
At any time during the exam, the operator can view and modify the patient's data
with and can also select a different probe and setting by using and .
Do not use to begin a new exam as this will update the existing
W A R N I N G
patient’s information with new entries. To activate a new procedure, always
use the key.
To select fields and options, use the trackball and the ENTER key: The trackball
moves the cursor; the ENTER key fixes the cursor’s position, opens the drop-down
menu and selects the option.
• To move rapidly through the different items, use the Tab ' key.
• Select the required application, preset and probe. The selected
application and presets are displayed over a black background, and the
selected probe is displayed over a blue field.
• Move the cursor over OK and press ENTER to begin the exam.
The system activates Real-Time in 2D. The selected application and presets
automatically determine the type of format, CFM maps and power values …
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Before beginning the exam, make sure that the active probe displayed on
W A R N I N G
the screen matches the one selected on the Exam Start page.
Exam End To end the exam, press the key again. The window displayed at the end of the
exam is used to archive the exam. This window shows the patient's first name, the
type of activated application and the dimensions of the stored images.
Further details are Before archival, the patient data can be made anonymous. The exam can be
provided in the data simultaneously archived and exported and the corresponding report can be saved
archival chapter.
on an external medium.
The system automatically shows the window at the beginning of the exam.
Note
ECG
When the electrodes have been applied and connected, the position of the ECG
trace on the screen can be selected, and the gain may be adjusted.
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For formats which contain a trace (M-Mode and Doppler), prior to activating the
mode, the user must press the LINE key to display the scanning line.
Line cursor
During scanning, the UPDATE key freezes the trace and re-activates the 2D
reference; the P L E X key activates or freezes the 2D reference, maintaining the
trace in Real Time.
The keyboard and commands displayed on the software keys menu make it
possible to optimize presentation quality. Different menus correspond to each
format. If the displayed menu has several levels, press the N E X T /P R E V I O U S key
to scroll through all functions.
To save images and image sequences (2D or CFM), press and in Real-
Time. Single images are saved with full definition; sequences are compressed.
For further Sequences, or clips, are compressed in Jpeg format, with a minimum loss of
information about information.
clip formats, consult
the “Advanced
Operations” manual. Note
Digital data storage is typically slower than the ultrasound frame rate;
the clip frame rate may be lower than the original rate. A Warning
message is displayed if the archival frame rate drops below 20 fps,
which may occur if multiple tasks (example: burning a CD and saving
new clips) are operating simultaneously.
The thumbnails of the saved data are shown in chronological order. A maximum
of eight thumbnails are shown: the colored arrow in the thumbnails column
indicates that further images are available for scrolling.
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For multiple formats, several scrolling bars are displayed; the ACTION key switches
over from one bar to the other; the trackball scrolls through the images of the
Trackball icon
selected bar.
In freeze the sequence of stored images can be seen in cine mode if the P L A Y key
is active. The sequence can be seen again at different speeds (use the S P E E D key).
The C I N E M O D E key displays the entire contents of the memory (when enabled
on F U L L ) or single cardiac cycles , when the ECG is shown, or seconds intervals
when there is no ECG. Use the trackball to scroll along the bar and display another
cycle/interval. If the option E X T R A C T has been selected, the user can extract from
the archived material a sequence of any desired length, by selecting the initial and
the final frame. Follow the screen instructions to extract the desired sequence.
The single cardiac cycles and the intervals selected through the C I N E MODE key
can be saved by pressing the CLIP key.
Exam Review
During the exam, the EXAM REV key enables the operator to review the saved
images and sequences. When the EXAM REV key has been pressed, the trackball
automatically changes over to pointer mode, allowing the operator to scroll
through the thumbnails and select the data item to be reviewed. The software
S C R O L L key enables the operator to scroll through the thumbnails when more
than eight images or sequences have been saved. If there are more than eight saved
images and clips, the P A G E sofware key allows the operator to quickly scroll the
thumbnails: the next eight thumbnails are displayed when the key is pressed.
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The selected image or sequence is presented on the screen. Clips are presented in
cine mode: the P L A Y key disables the kinetic presentation and enables the operator
to scroll through the sequence image-by-image with the trackball.
Note
The key A T T A C H attaches the selected image to the report: in this case the letter
“A” is displayed in the bottom left part of the screen, whenever the user reviews an
image attached to the report.
Image Clearing To clear a saved image or sequence, select the thumbnails by highlighting the
corresponding box and press the D E L E T E key.
In Exam revision single cardiac cycles and intervals selected thorugh the CINE
MODE key can be saved as clip by pressing the corresponding key.
Annotations
If any of the alphanumeric keys are pressed during the exam, this automatically
activates the input of text. All writing operations are managed by the alphanumeric
keyboard and trackball, the latter being used to position the cursor.
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Once the operation has been completed, press the keyboard ON/OFF button to
turn the system off.
Note
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6-8
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Chapter
7 - Measurements and
Calculations
This chapter describes how to access the generic measurements and the specific
calculation packages of the applications.
General Information
Measurements can be made on frozen, stored and archived images. The available
measurements are shown to the right of the image. The messages displayed on the
screen guide the operator through the stages, facilitating measurement execution.
The results are shown to the left of the image.
Clips are compressed for digital storage. Compressed files involve a minimal loss
of information (see Technical Specifications Chapter 11). The Compression
algorithm used by M y L a b ensures the preservation of the image features for the
reporting functions.
This symbol is displayed on the screen when the image features, compared to the
W A R N I N G
original one, may not be optimal for the reporting functions.
To select the views and the positioning of the cursors, Esaote urges the
operator to act according to current medical practice and the instructions of
specialists on this subject.
Note
If possible, use the full screen formats for M-Mode and Doppler
measurements.
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Generic Measurements
The generic measurements feature allows the user to make rapid measurements,
for example: distance, area, time and speed.
The key activates the generic measurements menu. The system displays the
list of available measurements, which are automatically identified according to the
active mode and application. The software M E A S U R E key is used for rapid
selection of the required measurement. The measurement shown in yellow is
immediately operational.
Following the instructions displayed on the monitor, position the cursors with the
trackball and confirm the position by pressing ENTER. The UNDO key can be used
to restart a measurement before it has been confirmed. The Back Space deletes
point by point the traced line. The value being measured is displayed in Real Time
on the left side of the image.
To access the specific calculations, press the MEASURE. key. The system
automatically identifies the calculations package according to the selected mode
and application.
The list of executable measurements is shown on the right side of the screen. The
measurements are arranged in groups (identified by the symbol ), which
correspond to specific anatomical structures. Each group includes the
measurements executable in that structure. To display the measurements included
in a group, position the trackball on the group and press the E X P A N D key.
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The ACTION key allows to interrupt the active measure and select a different group..
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Chapter
8 - Exams Archive
This chapter describes how to archive images and to access the relevant archive.
Archive Icons
When the system accesses the archive, the relevant archive icons are shown on the
right of the heading bar. The active icon is displayed on a dark background, while
the icons that can be activated are shown over a blue background. Icons shown in
grey are inactive.
To activate the function, locate the trackball over the required icon and press .
Data Archival
MyLab has an internal hard disk in which the exams can be archived (local archive).
The data can be saved on external supports and on DICOM® format (for systems
having a DICOM license), and exported in BMP format or AVI format (see
specification for codec information). Exported data cannot be reviewed by the
system.
The and keys save single images (with full resolution) and image
sequences (in compressed format). When the CLIP key is pressed, the system stores
sequences of a preset duration, which can be set from the System Menu (see
“Advanced Operations” manual). Data is compressed with a minimum loss of
information, with a maximum frame rate of about 25 images.
Note
Digital data storage is typically slower than the ultrasound frame rate;
the clip frame rate may therefore be lower than the original one. A
Warning message is displayed if the archival frame rate drops below 20
fps, as it may occur if multiple tasks (example: burning a CD and
saving new clips) are concurrently working.
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Archiving the During an exam, the images are temporarily stored on the system's hard disk. The
Exam exam ends as soon as the START END key is pressed. The system shows the window
of the exam end, which enables the operator to select the required format(DICOM
with the DICOM option; BMP or AVI with the EXPORT option; native format with
the ARCHIVE option) and the final archival support. The same window allows to
enable the storing of the report (in XML format) on a selectable external medium.
When the exam is archived on Cdor DVD in DICOM format, the Biopacs Lite1
viewer is automatically enclosed in the CD or DVD. In this way the exam can be
reviewed in any PC.
Archival Procedure • If necessary, use the trackball to enable archival and export of the exam
• Select the required supports.
• Locate the cursor on OK and press to confirm.
While data are being saved, the icon for the relevant destination support is outlined
by a yellow flashing frame. The frame disappears when the operation ends.
Do not switch off the system nor remove the archiving medium while data is
C A U T I O N
being saved (yellow flashing frame on the destination support). The data and
the hard disk could be damaged. If necessary, you may run the Shut Down
procedure to interrupt and safely power off the system.
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The system displays the list of archived exams and enables the operator to
selectively choose the exams to be reviewed, setting query criteria such as the
patient’s first name, the application and the exam date.
The R E S E T key • Use the trackball and alphanumeric keyboard to input the search criteria.
deletes the set search
criteria. • Locate the pointer on QUERY and press to activate the search.
At the end of the search, a list of the exams within the set criteria is presented on the
screen. The S C R O L L key enables the operator to scroll inside the list and select the
specific exam. To select several exams, use the trackball to position the cursor and
press the Ctrl and keys simultaneously.
After selecting, activate the archive display icon to access the data. The list of
selected exams is displayed on the right of the screen next to the thumbnails. Use
Archive display icon the trackball to locate the cursor on the required exam and press to confirm.
The system is in exam review status, and, therefore, the same instructions apply.
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The operator can also control the data transfer operations. Locate the cursor on the
icon of the specific support and press .
The displayed interactive window enables the operator to follow the operation.
The crossed out icon indicates management problems of the specific archival
support. The interactive window allows the operator to understand which operation
has failed, and, if necessary, to repeat (RETRY) or cancel the failed operation.
Do not switch off the system nor remove the archiving medium while data
C A U T I O N
are being saved ( yellow flashing frame on the destination support). The data
and the hard disk could be damaged. If necessary, you may run the Shut
Down procedure to interrupt and safely power off the system.
Writable CDs
Empty disks must be used. If the CD contains data, the system will not allow
writing and shows the following message:
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Rewritable CDs
Rewritable CDs may be used for archiving data providing such CDs are empty.
The system allows the deletion of data stored on rewritable CDs. Locate the cursor
on the CD icon and press . The system displays the CD management menu:
CD icon select "ERASE DEVICE" and press .
Rewritable DVDs
Empty single-layer DVDs must be used; if the DVD already contains some data,
the system won’t allow to burn them .
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Chapter
9 - System Menu
This chapter describes how to set and configure the system.
Configuration Menu
The MENU key provides access to the system menu. The key can be pressed both in
any environment. The system displays the available options.
General Preset
The available options are internally organized in folders. To access the individual
folders, position the trackball on the required folder and press ENTER.
Parameter Setting • Position the trackball on the field to be altered and press ENTER to
confirm.
• Use the alphanumeric keyboard to type in characters.
• In the window menus, select the option and press ENTER to confirm.
• Press OK to confirm.
The Tab ' key is used to move quickly from field to field; the Pgup c and Pgdn d
keys open the window menus and scroll among the relevant options. After the
modifications have been confirmed, the system displays the following message:
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M y L a b 5 0 – G E T T I N G S T A R T E D
Date/Time
Date/Time enables the operator to change the date and time, and to select the
required data and time formats (12 or 24 hour).
Center
Center is used for inputting the name of the hospital/clinic, which will then be
shown on the screen.
Video
Video is used for selecting the required video standard (PAL or NTSC) and the
video signal (S-VHS or VHS).
Measure Units
The temperature scale can be set to Celsius or Fahrenheit. It is also possible to set
measure units for height and weight.
Cine
The option allows the user to define the default size of the memory to be used for
sequences and to set the default speed.
Archival
When set to auto, the unit automatically saves the exam, per user preset, at the end
of the exam without displaying the end exam window.
Trackball
The menu allows the user to set the functioning mode of the trackball left key. The
key can be configured as the enter key (ENTER) or as the context menu key (UNDO).
Other
The option allows to define whether the frame rate shall be displayed.
Application Preset
This option allows to modify and save both the gray map used in the active
application and the configurable parameters of the XView algorythm.
User Preset
This procedure allows the user to create a new preset (ADD option), and to modify
(EDIT option) or cancel and existing one (CLEAR option) forstandard applications.
The set presets can be selected on the page allowing the exam start or with the
PRESET button.
Parameter Setting
The menu is organized into one general folder four mode folders and till four
probe folders.
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General Folder With the General Folder menu, the operator can assign a name to the new preset
and associate a new application with it from among the available applications. The
operator can set general parameters such as the display of the ECG trace, clips
duration, and the final archival support for the exam.
Mode Folders Each mode (B-Mode, CFM, M-Mode and Doppler) has a specific folder, where
different parameters can be set.
To save the settings, press SAVE: the set presets will become operable when the
system is next powered up. The CLOSE key closes the menu without saving any
modifications that have been made.
The factory presets for the required application (FACTORY SETTINGS key) can be
set from the same window.
Probe Folders For the active preset the system allows to configure four probes. Each probe can
be individually configured. As soon as a probe has been selected, the system shows
its parameters.
Parameters are gourped in three settigns types: power values, other parameters
(number of transmission focuses, 2D sector size etc) and gains.
To save the settings, press SAVE: the set presets will become operable when the
system is next powered up. The CLOSE key closes the menu without saving any
modifications that may have been made.
Tools Preset
This option allows to modify the labels used in Stress Echo to identify the single
views, to set Stress and CnTI protocols, and to configure the 3D display profiles.
Report Customization
MyLab offers different menus allowing configuration of the desired report. The
following table lists the available setting options ( key):
Option Setting
Report Header Headers setting
Report Print Layout Selection of data to be printed.
Edit Report Observations Observations setting.
Report Print Layout Selection of the template.
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This option allows the user to choose which data must be inserted into the report,
to create a glossary for use when writing the report, or to customize the print
layout.
The “System Menu” section of the "Advanced Operations" manual details how to
AO configure the report.
Application Measurements
This option allows configuration of the available measurement packages by using
the key. MyLab allows programming of different packages for each
application. For each measurement group, a description may be entered and the
derived measurement enable.
Generic Measurements
This option allows to program the generic measurements available for each
application.
Glossary
When in annotation mode, the system allows the user to enter pre-existing
sentences or words. Through this option, applications libraries of words can be
created.
Peripherals
The system can remotely control (with keys 1 and 2) recording by VTR (for specific
models) and printing (in B&W and color).
The menu also enables the operator to select the required print format. The set
printing format icon is displayed next to the relevant printer symbol, in the heading
bar.
Do not switch the system off until the printing stage has been completed.
C A U T I O N
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Dicom Configuration
This option allows configuration of the Dicom servers and printers to which the
MyLab is connected.
Security
This option allows to define the list of users allowed to work on the system: in this
case the access to the system can occur only through a log in procedure, by
entering a password.
Service
This option is strictly for service use and its details are provided in the system
Service Manual.
System Configuration
This option displays the system's hardware and software configuration. If a demo
license is installed, it is possible to control its expiration date in the corresponding
folder.
Licenses
The license number can be input from this option. The license becomes functional
at the next power up..
Shut Down
This option allows to shut down the system. This procedure can be used as an
alternative to pressing the STARTEND key .
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M y L a b 5 0 – G E T T I N G S T A R T E D
Chapter
10 - System
Maintenance
This chapter describes the system's main maintenance operations.
To clean the peripheral units, follow the instructions supplied by the manufacturer.
Cleaning the To clean the system, use a soft cloth slightly dampened with water. If necessary,
system apply a small amount of ammonia- and alcohol-free, not abrasive detergent onto a
clean, soft cloth and then wipe the surface. Switch the system off and rub the
outside with the cloth.
Make sure that the detergent has completely evaporated before turning on
W A R N I N G
the equipment.
Trackball The trackball can be accessed by dismantling the keyboard group. Contact Esaote
personnel if cleaning is necessary.
Cleaning the Probe Probe and gel holders are easily removed from their location for cleaning and can
and Gel Holders be washed in a mild soap solution. Make sure they are completely dry prior to
replacing them.
Monitor and LCD To clean the monitor or the LCD, switch the unit off from the rear main switch.
Never spray or pour any liquid directly onto the screen or case.
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Gently wipe the screen with a slightly dump (not wet) soft cloth to remove
dust and other particulate matter.
To clean the screen or
the LCD
If necessary, apply a small amount of ammonia- and alcohol-free glass
cleaner onto a clean, soft cloth and then wipe the surface.
To clean the case Use a soft, dry cloth to wipe the surface of the case.
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M y L a b 5 0 – G E T T I N G S T A R T E D
Chapter
11 - Technical
Specifications
This chapter describes the technical specifications1 of the MyLab product.
AO Note
Special packages (such as Stress Echo) are listed and described in the
specific sections of the Advanced Operations manual.
MyLab50 Configuration
Basic MyLab50 basic configuration consists of an imaging system licensed for one or
Configuration more of the following applications:
Optional Modes The system can be licensed for the following additional modes:
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M y L a b 5 0 – G E T T I N G S T A R T E D
License Feature
Clip Clip digital storage
Stress Stress Echo
XView XView algorithm
DICOM DICOM classes
CnTI Contrast
V-Pan Panoramic View
3D/4D 3D and 4D
Xstrain Strain and Strain Rate
Probes Licenses The following table summarizes licenses requirements:
Refer to the next License Feature
pages for probes types Phased Array License Necessary for Phased Array , TEE022 and TE122
probes management
Linear and HF License Necessary for Linear Array, Intraoperative,
Laparoscopic and CA123 probes management
Convex License Necessary for Convex Array, EC123 and BC431
probes management
Doppler probes do not require any specific license.
MyLab50CV Configuration
Basic MyLab50CV basic configuration consists in the CFM system licensed for the
Configuration following application:
Optional MyLab50CV can be equipped with one or more of the following applications:
Applications
License Application Features
Vascular Peripheral Vascular, Adult Presets, Calculations
cephalic
General Imaging Abdomen, Pediatric, Presets, Calculations
Muscolo-Skeletal, Breast,
Small Parts, Thyroid
Breast Breast Presets, Calculations
Thyroid Thyroid Presets, Calculations
Musculo-Skeletal Muscolo-Skeletal Presets, Calculations
11-2
M y L a b 5 0 – G E T T I N G S T A R T E D
License Feature
Clip Clip digital storage
XView XView algorithm
Stress Stress Echo
DICOM DICOM classes
CnTI Contrast
V-Pan Panoramic View
3D/4D 3D and 4D
XStrain Strain and Strain rate
MyLab50XVsion Configuration
Basic MyLab50XVision basic configuration consists of an imaging system. The system can
Configuration store and export (BMP format) still frames only .
Optional The system can be integrated with one or more of the following applications:
Applications
License Application Features
Cardiac Cardiac, Cardiac Pediatric Presets, Calculations, ECG
Vascular Peripheral Vascular, Adult Presets, Calculations
Cephalic
General Imaging Abdomen, Pediatric, Presets, Calculations
Muscolo-Skeletal, Breast,
Small Parts, Thyroid
Breast Breast Presets, Calculations
Thyroid Thyroid Presets, Calculations
Musculo-Skeletal Muscolo-Skeletal Presets, Calculations
Urology Urology Presets, Calculations
11-3
M y L a b 5 0 – G E T T I N G S T A R T E D
Optional Modes The system can be licensed for the following additional modes:
License Feature
Clip Clip digital storage
XView XView algorithm
Stress Stress Echo
DICOM DICOM classes
CnTI Contrast
V-Pan Panoramic View
3D/4D 3D and 4D
Xstrain Strain and Strain Rate
Display
• CRT 17” SVGA (MyLab50 and MyLab50CV)
• LCD 19” XVGA (MyLab50XVision)
Probe connectors
• 3 electronic probes
• 1 Doppler probe
11-4
M y L a b 5 0 – G E T T I N G S T A R T E D
Video I/O
• XVGA output (display)
• XVGA output (auxiliary display)
• S-VHS I/O
• VHS Input
• VHS B/W output
• RGB (TV standard)
• Video standard
• PAL / NTSC (software controlled)
Connectivity
• I/Os connectors
• Serial RS-232
• LAN RJ45
• 4 USB
• Dedicated connectors
• Audio I/O (stereo)
• ECG input
• Foot switch
• External trigger input
• Auxiliary input
• Others
• Laser/Ink-jet printers
• Complying with IHE integration profiles4
Image Files
• Formats
• Standard output file formats (BMP, AVI)
• Native and DICOM formats
• Clips characteristics
• AVI Codec: Microsoft® MPEG4-V2
• Compression: JPEG lossy compression (approximately 70% of quality)
• Frame rate: about 25 fps max.
• Still frames / BMPs are stored at full resolution
• Triggered acquisition
• Graphic overlays
• Reports
Software
• Operating system: WIN XP Embedded
• Multi-lingual
Biometry
• Basic and advanced calculation, application dependent
• Annotations, Body Marks
Keyboard
• Echografic
• Sliders for TGC
• Encoders for general gains
• Keys for modes, peripherals management and controls
11-5
M y L a b 5 0 – G E T T I N G S T A R T E D
Power Cables
• Power cable with CEE socket
• Socket type and amperage: EN60320/C19 type; 16A-250V
• Plug: VII (7) VII type; 16A-250V
• Conductors: 3
• Section: 1,5 mm2
• Length: 2,5 m
• Power with CEI socket
• Socket type and amperage: EN60320/C19 type; 16A-250V
• Plug: I/3/16 type; 16A-250V
• Conductors: 3
• Section: 1,5 mm2
• Length: 2,5 m
• Power with NEMA socket
• Socket type and amperage: EN60320/C19 type; 15A-250V
• Plug: NEMA-15 type; 15A-250V
• Conductors: 3
• Section: AWG 14
• Length: 2,5 m
Dimensions
• approximately 63 (w) x 143÷150 (h) x 102 (d) cm in working position
• approximately 63 (w) x 143 (h) x 90 (d) cm when being transported
Weight
• approximately 100 kg
Power supply
• Voltage operative range
• 100 ÷ 120V
• 200 ÷ 240 V
• Voltage limit range
• 90 ÷ 132V
• 180 ÷ 264 V
• Mains frequency: 45 ÷ 65 Hz
• Power consumption: ≤ 1000 VA
• Available power on peripherals: up to 600 VA
Operating requirements
• Temperature: 15÷35°C
• Humidity: 15÷95 % (not condensing)
• Pressure: 700÷1060 hPa
Storage requirements
• Temperature: -20 ÷ +60°C
• Humidity: 5÷95 % (not condensing)
• Pressure: 700÷1060 hPa
Safety Standards
• EN 60601-1
• EN 60601-1-1
• EN 60601-1-2
• EN 60601-1-4
• EN ISO 10993-1
• EN 60601-2-37
• EN 61157
• AIUM / NEMA UD-2 / UD-3 – FDA 510(k) Track 3
11-6
M y L a b 5 0 – G E T T I N G S T A R T E D
Probes
Speciality Probes
Probe ID
TEE022
TEE122
EC123
E8-5
IOE323
LP323*
BC431
*not for the U.S. market
Doppler Probes
Probe ID
2CW
5CW
11-7
M y L a b 5 0 – G E T T I N G S T A R T E D
System Accessories
ECG Cables and consumables are listed in the “Transducers and Consumables”
Manual. The MyLab can be equipped with a foot-switch (Reference: 9102756000).
Video Requirements
RGB Printer • Input: RGB SYNC
• RGB (analog): 0.7 Vp-p, 75 ohm
• SYNC : 5 Vp-p
• Connectors: standard BNC
• Safety standard: IEC 950 o EN60601-1
11-8
A
– G E T T I N G S T A R T E D
Appendix
M y L a b 5 0
Appendix A - Acoustic
Output Tables
Acoustic Output Data according to FDA
This section includes the acoustic output tables for each probe and mode of operation (tables
structure and measurements precision according to the document “Information for Manufacturers
Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers” issued by the
FDA on september 30, 1997).
Summary Table
For transducer/mode combinations marked "yes", MI or TI index is equal or greater than 1.0.
Mode PA230 PA121 PA122 PA023 LA522 LA523 IOE323/L 2CW 5CW
P323
B/M Yes Yes Yes Yes Yes Yes Yes N/A N/A
TEI (B/M) Yes Yes N/A N/A Yes Yes N/A N/A N/A
CFM (B/M) Yes Yes Yes Yes Yes Yes Yes N/A N/A
PW Yes Yes Yes Yes Yes Yes Yes N/A N/A
CW Yes Yes Yes Yes N/A N/A N/A Yes Yes
CnTI Yes N/A N/A N/A N/A N/A N/A N/A N/A
Mode LA424 LA532 CA421 CA621 CA430 CA123 EC123 TE022 TE122
B/M Yes Yes Yes Yes Yes Yes Yes Yes Yes
TEI (B/M) N/A Yes Yes No Yes Yes No Yes Yes
CFM (B/M) Yes Yes Yes Yes Yes Yes Yes Yes Yes
PW Yes Yes Yes Yes Yes Yes Yes Yes Yes
CnTI N/A No N/A N/A No N/A N/A N/A N/A
A-1
M y L a b 5 0 – G E T T I N G S T A R T E D
A-2
M y L a b 5 0 – G E T T I N G S T A R T E D
A-3
M y L a b 5 0 – G E T T I N G S T A R T E D
A-4
M y L a b 5 0 – G E T T I N G S T A R T E D
A-5
M y L a b 5 0 – G E T T I N G S T A R T E D
A-6
M y L a b 5 0 – G E T T I N G S T A R T E D
A-7
M y L a b 5 0 – G E T T I N G S T A R T E D
A-8
M y L a b 5 0 – G E T T I N G S T A R T E D
A-9
M y L a b 5 0 – G E T T I N G S T A R T E D
A-10
M y L a b 5 0 – G E T T I N G S T A R T E D
A-11
M y L a b 5 0 – G E T T I N G S T A R T E D
A-12
M y L a b 5 0 – G E T T I N G S T A R T E D
A-13
M y L a b 5 0 – G E T T I N G S T A R T E D
A-14
M y L a b 5 0 – G E T T I N G S T A R T E D
A-15
M y L a b 5 0 – G E T T I N G S T A R T E D
A-16
M y L a b 5 0 – G E T T I N G S T A R T E D
A-17
M y L a b 5 0 – G E T T I N G S T A R T E D
A-18
M y L a b 5 0 – G E T T I N G S T A R T E D
A-19
M y L a b 5 0 – G E T T I N G S T A R T E D
A-20
M y L a b 5 0 – G E T T I N G S T A R T E D
A-21
M y L a b 5 0 – G E T T I N G S T A R T E D
A-22
M y L a b 5 0 – G E T T I N G S T A R T E D
A-23
M y L a b 5 0 – G E T T I N G S T A R T E D
A-24
M y L a b 5 0 – G E T T I N G S T A R T E D
A-25
M y L a b 5 0 – G E T T I N G S T A R T E D
A-26
M y L a b 5 0 – G E T T I N G S T A R T E D
A-27
M y L a b 5 0 – G E T T I N G S T A R T E D
A-28
M y L a b 5 0 – G E T T I N G S T A R T E D
A-29
M y L a b 5 0 – G E T T I N G S T A R T E D
A-30
M y L a b 5 0 – G E T T I N G S T A R T E D
A-31
M y L a b 5 0 – G E T T I N G S T A R T E D
A-32
M y L a b 5 0 – G E T T I N G S T A R T E D
A-33
M y L a b 5 0 – G E T T I N G S T A R T E D
A-34
M y L a b 5 0 – G E T T I N G S T A R T E D
A-35
M y L a b 5 0 – G E T T I N G S T A R T E D
A-36
M y L a b 5 0 – G E T T I N G S T A R T E D
A-37
M y L a b 5 0 – G E T T I N G S T A R T E D
A-38
M y L a b 5 0 – G E T T I N G S T A R T E D
A-39
M y L a b 5 0 – G E T T I N G S T A R T E D
A-40
M y L a b 5 0 – G E T T I N G S T A R T E D
A-41
M y L a b 5 0 – G E T T I N G S T A R T E D
A-42
M y L a b 5 0 – G E T T I N G S T A R T E D
A-43
M y L a b 5 0 – G E T T I N G S T A R T E D
A-44
M y L a b 5 0 – G E T T I N G S T A R T E D
A-45
M y L a b 5 0 – G E T T I N G S T A R T E D
A-46
M y L a b 5 0 – G E T T I N G S T A R T E D
A-47
M y L a b 5 0 – G E T T I N G S T A R T E D
A-48
M y L a b 5 0 – G E T T I N G S T A R T E D
A-49
M y L a b 5 0 – G E T T I N G S T A R T E D
A-50
M y L a b 5 0 – G E T T I N G S T A R T E D
A-51
M y L a b 5 0 – G E T T I N G S T A R T E D
A-52
M y L a b 5 0 – G E T T I N G S T A R T E D
A-53
M y L a b 5 0 – G E T T I N G S T A R T E D
A-54
M y L a b 5 0 – G E T T I N G S T A R T E D
A-55
M y L a b 5 0 – G E T T I N G S T A R T E D
A-56
M y L a b 5 0 – G E T T I N G S T A R T E D
A-57
M y L a b 5 0 – G E T T I N G S T A R T E D
A-58
M y L a b 5 0 – G E T T I N G S T A R T E D
A-59
M y L a b 5 0 – G E T T I N G S T A R T E D
A-60
M y L a b 5 0 – G E T T I N G S T A R T E D
A-61
M y L a b 5 0 – G E T T I N G S T A R T E D
A-62
M y L a b 5 0 – G E T T I N G S T A R T E D
A-63
M y L a b 5 0 – G E T T I N G S T A R T E D
A-64
M y L a b 5 0 – G E T T I N G S T A R T E D
A-65
M y L a b 5 0 – G E T T I N G S T A R T E D
A-66
M y L a b 5 0 – G E T T I N G S T A R T E D
A-67
M y L a b 5 0 – G E T T I N G S T A R T E D
A-68
M y L a b 5 0 – G E T T I N G S T A R T E D
A-69
M y L a b 5 0 – G E T T I N G S T A R T E D
A-70
M y L a b 5 0 – G E T T I N G S T A R T E D
A-71
M y L a b 5 0 – G E T T I N G S T A R T E D
A-72
M y L a b 5 0 – G E T T I N G S T A R T E D
A-73
M y L a b 5 0 – G E T T I N G S T A R T E D
A-74
M y L a b 5 0 – G E T T I N G S T A R T E D
A-75
M y L a b 5 0 – G E T T I N G S T A R T E D
A-76
M y L a b 5 0 – G E T T I N G S T A R T E D
A-77
M y L a b 5 0 – G E T T I N G S T A R T E D
A-78
M y L a b 5 0 – G E T T I N G S T A R T E D
A-79
M y L a b 5 0 – G E T T I N G S T A R T E D
A-80
M y L a b 5 0 – G E T T I N G S T A R T E D
A-81
M y L a b 5 0 – G E T T I N G S T A R T E D
A-82
M y L a b 5 0 – G E T T I N G S T A R T E D
A-83
M y L a b 5 0 – G E T T I N G S T A R T E D
A-84
M y L a b 5 0 – G E T T I N G S T A R T E D
A-85
M y L a b 5 0 – G E T T I N G S T A R T E D
A-86
M y L a b 5 0 – G E T T I N G S T A R T E D
A-87
M y L a b 5 0 – G E T T I N G S T A R T E D
A-88
M y L a b 5 0 – G E T T I N G S T A R T E D
A-89
M y L a b 5 0 – G E T T I N G S T A R T E D
A-90
M y L a b 5 0 – G E T T I N G S T A R T E D
A-91
M y L a b 5 0 – G E T T I N G S T A R T E D
A-93
M y L a b 5 0 – G E T T I N G S T A R T E D
CA431 (Reference: 960 0177 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM D+BCFM DI
Parameter B M B-TEI M-TEI P I P I p
Ð
p_(MPa) 4.4 4.4 3.4 2.5 4.1 3.2 3.5 3.3 3.9 2.1
Ispta (mW/cm2) 140 826 245 772 388 868 1080 1191 892 1387
System settings a SS/SD =
F=5 F=6 F=8 F=6 F=8 F=8 F=8 F=7 F=7 2/107mm
Ip (mm) 39 44 48 40 48 48 48 45 45 45
wpb6 ( | | ) (mm) 4.2 6.8 8.1 4.7 8.3 8.3 8.3 7.3 7.3 7.3
wpb6 ( | ) (mm) 5.4 4 4.2 4.2 4 4 4 4.1 4.1 4.1
prr (kHz) 5.6 5.6 3.9 5.6 1 3.7 3.7 4.2 4.2 5.6
srr (Hz) 82 - 89 82 10 38 38 44 44 -
Output beam dimension ( || ) (mm)b 9.6 10.8 12.6 10.8 12.6 12.6 12.6 12 12 12
Output beam dimension ( | ) (mm)b 12 12 12 12 12 12 12 12 12 12
fawf (MHz) 3.5 3.5 2.2 2.2 2.5 2.5 2.5 2.5 2.5 2.5
APF c (%) - - - - - - - - - -
AIF d (%) 100 99 76 57 93 72 79 75 88 47
Maximum power e (mW) 234.6 259.9 239.9 190 150.5 328.1 248.1 249.5 325.9 290.6
Iob (mW/cm2) 204 199.9 158.8 146.1 99.7 217.3 164.3 173.2 226.3 201.8
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + D B+D
M-CFM M-CFM B+D B-CFM+D
A-94
M y L a b 5 0 – G E T T I N G S T A R T E D
CA631 (Reference: 960 0185 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM Dp DI
Parameter B M B-TEI M-TEI P I P I
Ð
p_(MPa) 3.8 3.8 3.4 3.1 4.2 3.4 5 3.8 4.5 2.8
Ispta (mW/cm2) 32 321 30 926 1318 1452 307 1703 1877 1900
System settings a SS/SD = SS/SD =
F=5 F=5 F=6 F=7 F=7 F=7 F=7 F=7 2/104mm 2/104mm
Ip (mm) 48 48 47 51 57 57 61 61 61 61
wpb6 ( | | ) (mm) 3.5 3.5 4.8 7.7 7.5 7.5 7.4 7.4 7.4 7.4
wpb6 ( | ) (mm) 2.7 2.7 3.5 3.8 3.2 3.2 2.8 2.8 2.8 2.8
prr (kHz) 2.6 2.6 2.6 4.8 2.8 4.8 0.5 4.8 2.1 5.6
srr (Hz) 26 - 26 49 36 62 6 62 - -
Output beam dimension ( || ) (mm)b 9.9 9.9 11.9 14.5 14.5 14.5 14.5 14.5 14.5 14.5
Output beam dimension ( | ) (mm)b 13 13 13 13 13 13 13 13 13 13
fawf (MHz) 3.2 3.2 2.3 2 2.5 2.5 3 3 3.3 3.3
APF c (%) - - - - - - - - - -
AIF d (%) 100 100 89 81 111 89 130 99 118 73
Maximum power e (mW) 43.6 43.7 51.3 309.6 297.1 326 44.9 249.2 274.6 278
Iob (mW/cm2) 33.8 33.9 33.3 163.8 157.2 172.5 23.7 131.9 145.3 147.1
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + B+D B+D
M-CFM M-CFM B-CFM+D B-CFM+D
A-95
M y L a b 5 0 – G E T T I N G S T A R T E D
CA621 (Reference: 960 0155 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM Dp DI
Parameter B M B-TEI M-TEI P I I
Ð
p_(MPa) 3.3 3.3 1.3 1.2 3.8 3.8 3.3 3.9 3.9
Ispta (mW/cm2) 180 411 41 316 474 474 1826 2054 2054
System settings a SS/SD = SS/SD =
F=5 F=5 F=7 F=6 F=6 F=6 F=6 2/67mm 2/67mm
Ip (mm) 42 42 55 49 49 49 49 52 52
wpb6 ( | | ) (mm) 3.5 3.5 6.5 3.7 3.7 3.7 3.7 3.1 3.1
wpb6 ( | ) (mm) 3.1 3.1 3.3 3.1 2.8 2.8 2.8 2.7 2.7
prr (kHz) 2.6 2.6 5.1 5.6 2.1 2.1 4.2 2.1 2.1
srr (Hz) 26 - 52 57 22 22 45 57 57
Output beam dimension ( || ) (mm)b 9.9 9.9 13.9 11.2 11.2 11.2 11.2 9.9 9.9
Output beam dimension ( | ) (mm)b 12 12 12 12 12 12 12 12 12
fawf (MHz) 2.5 2.5 2.5 2.6 3.1 3.1 3 3.2 3.2
APF c (%) - - - - - - - - -
AIF d (%) 100 100 54 53 118 118 103 119 119
Maximum power e (mW) 57.7 57.7 67.6 55.5 138.9 138.9 166.6 137.7 137.7
Iob (mW/cm2) 48.4 48.4 40.7 41.1 102.9 102.9 123.4 115.7 115.7
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B+D B+D
M-CFM B-CFM+D B-CFM+D
A-96
M y L a b 5 0 – G E T T I N G S T A R T E D
CA421 (Reference: 960 0154 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM Dp DI
Parameter B M B-TEI M-TEI P I P I
Ð
p_(MPa) 3.9 3.9 1.9 1.9 3.8 3.1 3.9 3.9 4.3 2.7
Ispta (mW/cm2) 147 829 59 400 121 516 1638 1638 2102 2216
System settings a SS/SD = SS/SD =
F=8 F=8 F=8 F=6 F=8 F=8 F=6 F=6 2/116mm 2/108mm
Ip (mm) 55 55 57 46 56 55 48 48 55 55
wpb6 ( | | ) (mm) 6.7 6.7 5.1 4.1 6.2 6 3.8 3.8 5 5
wpb6 ( | ) (mm) 3.5 3.6 4.4 4.4 3.7 3.9 4.5 4.5 3.3 3.3
prr (kHz) 4.4 4.4 4.2 5.6 1 4.2 4.2 4.2 2.1 5.6
srr (Hz) 62 - 58 72 8 32 35 35 32 32
Output beam dimension ( || ) (mm)b 12.6 12.6 12.6 10.8 12.6 12.6 10.8 10.8 12 12
Output beam dimension ( | ) (mm)b 12 12 12 12 12 12 12 12 12 12
fawf (MHz) 2.9 2.9 2.1 2.1 3.1 2.5 2.9 2.9 3.2 3.2
APF c (%) - - - - - - - - - -
AIF d (%) 100 101 49 48 97 80 100 100 111 68
Maximum power e (mW) 221 232.2 108.2 95.6 71.9 316.6 203.4 203.4 231.8 244.4
Iob (mW/cm2) 146.4 153.8 71.7 73.6 47.6 209.7 156.5 156.5 161 169.7
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + B+D B+D
M-CFM M-CFM B-CFM+D B-CFM+D
A-97
M y L a b 5 0 – G E T T I N G S T A R T E D
CA123 (Reference: 960 0158 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM D+BCFM DI
Parameter B M B-TEI M-TEI P I P I p
Ð
p_(MPa) 4.3 4.3 3.1 2.7 5.5 5.5 3.5 3.5 4.6 2.1
Ispta (mW/cm2) 89 862 46 469 187 187 1226 1226 1042 1624
System settings a SS/SD =
F=3 F=3 F=3 F=3 F=3 F=3 F=4 F=4 F=2 2/41mm
Ip (mm) 14 14 13 14 14 14 17 17 14 25
wpb6 ( | | ) (mm) 1.1 1.1 1.2 1.2 1 1 1.2 1.2 1 1.5
wpb6 ( | ) (mm) 1.6 1.6 1.7 1.6 1.4 1.4 1.4 1.4 1.7 1.7
prr (kHz) 4.4 4.4 4.4 5.6 2.8 2.8 5.6 5.6 5.6 11.1
srr (Hz) 80 - 81 93 18 18 35 35 35 58
Output beam dimension ( || ) (mm)b 4.9 4.9 4.9 4.9 4.9 4.9 5.6 5.6 4.2 6.7
Output beam dimension ( | ) (mm)b 4.2 4.2 4.2 4.2 4.2 4.2 4.2 4.2 4.2 4.2
fawf (MHz) 4.8 4.8 4.4 4.8 6.2 6.2 5.8 5.8 5.9 6.4
APF c (%) - - - - - - - - - -
AIF d (%) 100 100 72 62 128 128 82 82 107 49
Maximum power e (mW) 24.6 22.7 13.5 12.9 23.9 23.9 16 16 23.4 31.3
Iob (mW/cm2) 116.9 107.9 64.2 61.4 113.7 113.7 66.8 66.8 129.8 111.7
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + D B+D
M-CFM M-CFM B+D B-CFM+D
A-98
M y L a b 5 0 – G E T T I N G S T A R T E D
EC123 (Reference: 960 0157 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM Dp DI
Parameter B M B-TEI M-TEI P I P I
Ð
p_(MPa) 4.6 4.6 2.6 2.2 5.6 3.7 3.7 3.4 5 2.4
Ispta (mW/cm2) 150 724 22 168 368 465 976 1036 1308 1310
System settings a SS/SD = SS/SD =
F=3 F=5 F=3 F=3 F=6 F=8 F=6 F=3 2/46mm 2/46mm
Ip (mm) 10 11 12 12 14 15 14 13 18 18
wpb6 ( | | ) (mm) 1.3 2 1.6 1.6 2.6 3.3 2.6 1.3 2.9 2.9
wpb6 ( | ) (mm) 1.2 1.1 1.3 1.3 1.1 1.2 1.1 1.1 1.1 1.1
prr (kHz) 5.6 3.9 3.9 5.6 2.8 5.6 5.6 5.6 2.1 9.5
srr (Hz) 137 - 85 122 29 57 58 35 58 58
Output beam dimension ( || ) (mm)b 3.2 4 3.2 3.2 4.3 5 4.3 3.2 4.7 4.7
Output beam dimension ( | ) (mm)b 4.2 4.2 4.2 4.2 4.2 4.2 4.2 4.2 4.2 4.2
fawf (MHz) 5 5 4.9 4.9 6.1 5 5.8 5.9 6.3 6.3
APF c (%) - - - - - - - - - -
AIF d (%) 100 100 57 47 123 81 79 74 108 51
Maximum power e (mW) 22.4 19.5 4.2 4.3 26.8 40.8 16.7 10.4 27.7 27.7
Iob (mW/cm2) 160.3 114.5 30.1 31 148.8 194.2 92.9 74.1 138.3 138.5
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + B+D B+D
M-CFM M-CFM B-CFM+D B-CFM+D
A-99
M y L a b 5 0 – G E T T I N G S T A R T E D
LP323/IOE323 (Reference: 960 0162 000 / 960 0160 000)
ModeÎ Imaging Imaging BCFM BCFM MCFM MCFM D+BCFM DI
Parameter B M P I P I p
Ð
p_(MPa) 5.1 5.4 5.9 4.1 5.8 4.1 5.5 3.1
Ispta (mW/cm2) 28 98 196 709 196 1080 1062 1323
System settings a SS/SD =
F=3 F=3 F=4 F=8 F=4 F=3 F=3 2/30mm
Ip (mm) 12 12 14 13 14 11 12 17
wpb6 ( | | ) (mm) 1.1 1.2 1.7 5.2 1.7 1.2 1.1 2
wpb6 ( | ) (mm) 1.4 1.4 1.3 1.3 1.3 1.5 1.2 1.3
prr (kHz) 6.7 1 2.8 5.6 0.5 5.6 5.6 5.6
srr (Hz) 52 - 9 25 2 18 18 25
Output beam dimension ( || ) (mm)b 4.3 4.3 4.9 7 4.9 4.3 4.3 5.4
Output beam dimension ( | ) (mm)b 4 4 4 4 4 4 4 4
fawf (MHz) 5.8 5.8 6.4 6.5 6.2 6.1 6.2 6.5
APF c (%) - - - - - - - -
AIF d (%) 100 106 116 80 113 81 108 61
Maximum power e (mW) 11.8 2 28.2 69.5 3.2 14 22.8 26.4
Iob (mW/cm2) 68.2 11.4 145.2 247.4 16.6 81 132 122.3
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B-CFM + B-CFM + D B+D
M-CFM M-CFM B+D B-CFM+D
A-100
M y L a b 5 0 – G E T T I N G S T A R T E D
LA435 (Reference: 960 0173 000)
ModeÎ Imaging Imaging BCFM BCFM MCFM MCFM D+BCFM DI
Parameter B M P I P I p
Ð
p_(MPa) 5.9 5.7 6.1 5.3 6.1 5.1 5.6 3.1
Ispta (mW/cm2) 31 566 407 852 147 1155 748 1142
System settings a SS/SD =
F=5 F=5 F=7 F=8 F=5 F=6 F=5 2/22mm
Ip (mm) 10 10 9 9 9 11 9 11
wpb6 ( | | ) (mm) 1.2 1.2 2.4 3 1.3 1.6 1.3 1.6
wpb6 ( | ) (mm) 0.9 0.9 1.1 1.1 1.1 0.9 1.1 0.9
prr (kHz) 6.7 6.7 2.8 5.6 0.5 5.6 5.6 5.6
srr (Hz) 34 - 16 32 3 33 33 -
Output beam dimension ( || ) (mm)b 3.6 3.6 4.4 4.8 3.6 4 3.6 4
Output beam dimension ( | ) (mm)b 3.5 3.5 3.5 3.5 3.5 3.5 3.5 3.5
fawf (MHz) 9.4 9.5 7.8 7.9 7.7 7.7 7.7 7.9
APF c (%) - - - - - - - -
AIF d (%) 100 96 103 88 102 85 94 52
Maximum power e (mW) 9.6 9.5 25.1 53.2 1.4 12.8 13.6 12.7
Iob (mW/cm2) 75.8 75.7 163.2 317 11.2 91.5 107.6 90.6
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B-CFM + B-CFM + D B+D
M-CFM M-CFM B+D B-CFM+D
A-101
M y L a b 5 0 – G E T T I N G S T A R T E D
LA424 (Reference: 960 0149 000)
ModeÎ Imaging Imaging BCFM BCFM MCFM MCFM Dp DI
Parameter B M P I P I
Ð
p_(MPa) 5.4 6.1 6.3 3.9 6.2 4.3 6 5.8
Ispta (mW/cm2) 36 131 375 569 157 947 1216 1228
System settings a SS/SD = SS/SD =
F=5 F=5 F=6 F=8 F=7 F=3 2/29mm 2/26mm
Ip (mm) 9 9 10 7 12 8 14 14
wpb6 ( | | ) (mm) 1.2 1.2 1.5 3.2 1.8 0.8 1.5 1.5
wpb6 ( | ) (mm) 1.1 1.1 1 1.6 1 1.5 1 1
prr (kHz) 6.7 1 2.8 5.6 0.5 5.6 2.1 2.1
srr (Hz) 34 - 16 40 3 33 33 33
Output beam dimension ( || ) (mm)b 3.6 3.6 4 4.8 4.4 2.8 4.4 4.4
Output beam dimension ( | ) (mm)b 3 3 3 3 3 3 3 3
fawf (MHz) 8.9 8.9 7.9 7.9 7.6 7.8 8 8
APF c (%) - - - - - - - -
AIF d (%) 100 113 116 72 115 79 111 108
Maximum power e (mW) 13.4 2.3 22.9 38.4 2.5 7.1 13.7 13.8
Iob (mW/cm2) 123.9 21.7 191.1 266.5 19.1 85.1 103.9 104.9
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B-CFM + B-CFM + B+D B+D
M-CFM M-CFM B-CFM+D B-CFM+D
A-102
M y L a b 5 0 – G E T T I N G S T A R T E D
LA523 (Reference: 960 0156 000 / 960 0174 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM Dp DI
Parameter B M B-TEI M-TEI P I P I
Ð
p_(MPa) 5.1 5.5 4.2 4 6 4.8 6.1 4.1 5.3 5.2
Ispta (mW/cm2) 25 120 19 400 576 1201 192 1214 1224 1399
System settings a SS/SD = SS/SD =
F=3 F=3 F=3 F=4 F=5 F=7 F=5 F=3 2/18mm 2/29mm
Ip (mm) 14 14 13 14 15 12 15 13 13 16
wpb6 ( | | ) (mm) 1.1 1.1 1.2 1.4 2.2 4.7 2.2 1.1 1.1 2.1
wpb6 ( | ) (mm) 1 1 1 1.1 0.9 0.8 0.9 0.9 0.8 0.9
prr (kHz) 6.7 1 6.7 6.7 2.8 5.6 0.5 5.6 2.1 2.1
srr (Hz) 36 - 34 34 17 32 3 27 - -
Output beam dimension ( || ) (mm)b 4.4 4.4 4.4 4.9 5.4 6.9 5.4 4.4 4.4 5.4
Output beam dimension ( | ) (mm)b 5 5 5 5 5 5 5 5 5 5
fawf (MHz) 6.7 6.7 5.6 5.4 6.4 6.5 6.4 6.5 6.6 6.6
APF c (%) - - - - - - - - - -
AIF d (%) 100 110 83 78 120 94 120 81 105 102
Maximum power e (mW) 9.8 1.8 7.7 8.5 25.4 53.9 2.9 9.9 8.7 17.6
Iob (mW/cm2) 44.8 8 35.1 34.1 94 158.4 10.8 45.2 39.4 65
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + B+D B+D
M-CFM M-CFM B-CFM+D B-CFM+D
A-103
M y L a b 5 0 – G E T T I N G S T A R T E D
LA522 (Reference: 960 0163 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM Dp DI
Parameter B M B-TEI M-TEI P I P I
Ð
p_(MPa) 3.3 3.4 2.6 2.8 5.2 4 5.3 3.9 4.9 4.9
Ispta (mW/cm2) 36 132 31 529 513 1090 182 1260 1346 1832
System settings a SS/SD = SS/SD =
F=3 F=3 F=3 F=3 F=5 F=7 F=5 F=3 2/77mm 2/44mm
Ip (mm) 19 19 19 19 26 19 26 18 22 29
wpb6 ( | | ) (mm) 1.7 1.7 1.7 1.7 3.3 7 3.3 1.7 7.2 2.6
wpb6 ( | ) (mm) 1.9 1.9 2.1 2.1 2 1.7 2 1.8 1.6 1.9
prr (kHz) 6.7 1 6.7 6.7 2.8 5.6 0.5 5.6 2.1 2.1
srr (Hz) 34 - 34 34 12 23 - - - -
Output beam dimension ( || ) (mm)b 6.4 6.4 6.4 6.4 8.3 10.3 8.3 6.4 10.8 8.3
Output beam dimension ( | ) (mm)b 6 6 6 6 6 6 6 6 6 6
fawf (MHz) 4.8 4.8 4.1 4.1 4.7 4.7 4.5 4.6 4.8 4.9
APF c (%) - - - - - - - - - -
AIF d (%) 100 106 80 85 160 121 163 120 150 149
Maximum power e (mW) 26.2 4.7 25.2 25.2 68.7 134.4 7.8 26.7 103.3 55.6
Iob (mW/cm2) 68.8 12.5 66.4 66.4 137.4 216.7 15.6 70.2 158.9 111.3
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + B+D B+D
M-CFM M-CFM B-CFM+D B-CFM+D
A-104
M y L a b 5 0 – G E T T I N G S T A R T E D
LA532 (Reference: 960 0168 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM D+BCFM DI CnTI
Parameter B M B-TEI M-TEI P I P I p
Ð
p_(MPa) 3.8 3.8 3.3 3 6.2 3.9 5.5 4.7 4.7 3.5 1.1
Ispta (mW/cm2) 72 210 59 915 184 415 175 1427 344 1164 8
System settings a SS/SD =
F=3 F=3 F=6 F=5 F=6 F=6 F=6 F=5 F=5 2/56mm F=4
Ip (mm) 18 18 29 23 33 30 33 28 31 26 18
wpb6 ( | | ) (mm) 1.9 1.9 3.4 3.1 3.2 3.3 3.2 2.6 2.3 2.6 2.7
wpb6 ( | ) (mm) 2 2 3.5 2.8 2.6 3.2 2.6 2.2 2.2 2.6 2.4
prr (kHz) 6.7 1 6.7 6.7 2.8 5.6 0.5 5.6 5.6 2.1 8.3
srr (Hz) 34 - 34 34 10 21 2 22 22 21 22
Output beam dimension ( || ) (mm)b 6.4 6.4 9.3 8.3 9.3 9.3 9.3 8.3 8.3 9.3 7.3
Output beam dimension ( | ) (mm)b 6 6 6 6 6 6 6 6 6 6 6
fawf (MHz) 3.2 3.2 2.7 2.7 4.6 3.1 4 4.1 4.1 3.2 2.6
APF c (%) - - - - - - - - - - -
AIF d (%) 100 101 87 79 164 102 144 123 125 92 29
Maximum power e (mW) 55.9 9 77.1 98.4 37.7 123.2 9 53.5 18.4 55.1 14.6
Iob (mW/cm2) 147.1 23.7 137.8 196.9 67.3 220.1 16.2 107 36.8 98.4 32.4
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + D B+D
M-CFM M-CFM B+D B-CFM+D
A-105
M y L a b 5 0 – G E T T I N G S T A R T E D
TEE022 (Reference: 960 0170 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM Dp DI CW
Parameter B M B-TEI M-TEI P I P I
Ð
p_(MPa) 5 5 3.8 4 4.8 3 7.4 3.2 3.7 3.7 0.1
Ispta (mW/cm2) 55 295 20 268 148 185 343 839 692 692 452
System settings a SS/SD = SS/SD =
F=1 F=2 F=1 F=5 F=8 F=2 F=5 F=1 2/21mm 2/21mm F=1
Ip (mm) 18 29 17 44 44 29 40 18 16 16 13
wpb6 ( | | ) (mm) 0.8 1.4 1.1 2.8 2.9 1.8 2.2 0.6 0.7 0.7 1.2
wpb6 ( | ) (mm) 5.9 4.8 5.6 3.3 2.8 4.9 3.4 5.9 5.5 5.5 5.4
prr (kHz) 2.6 2.6 2.6 2.6 1.4 2.8 0.5 5.6 2.1 2.1 1
srr (Hz) 58 - 31 31 14 32 5 42 - - -
Output beam dimension ( || ) (mm)b 10.2 10.2 10.2 10.2 10.2 10.2 10.2 10.2 10.2 10.2 4.5
Output beam dimension ( | ) (mm)b 9.1 9.1 9.1 9.1 9.1 9.1 9.1 9.1 9.1 9.1 9.1
fawf (MHz) 4.7 4.4 4 3.5 4.8 3.3 4.8 5 5 5 5
APF c (%) - - - - - - - - - - -
AIF d (%) 100 100 77 80 96 60 148 64 75 75 3
Maximum power e (mW) 26.2 24.9 15.5 27.7 22.9 29 14.8 20.6 18.4 18.4 18.7
Iob (mW/cm2) 28.2 26.8 16.7 29.8 24.6 31.2 16 22.1 19.8 19.8 39.8
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + B+D B+D B+CW
M-CFM M-CFM B-CFM+D B-CFM+D B-
CFM+CW
A-106
M y L a b 5 0 – G E T T I N G S T A R T E D
TEE122 (Reference: 960 0186 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM Dp DI CW
Parameter B M B-TEI M-TEI P I P I
Ð
p_(MPa) 6.4 6.3 5.2 4.4 5.9 4.6 5.9 3 3.4 2.1 0.2
Ispta (mW/cm2) 85 532 68 636 130 551 292 901 795 810 966
System settings a SS/SD = SS/SD =
F=3 F=3 F=4 F=5 F=8 F=2 F=8 F=3 2/31mm 2/31mm F=7
Ip (mm) 26 26 27 28 26 22 26 24 22 22 21
wpb6 ( | | ) (mm) 1.7 1.7 2.2 2.3 1.9 2.8 1.9 2.2 2.8 2.8 2.6
wpb6 ( | ) (mm) 2.1 2.1 2.1 2.3 3.2 1.3 3.2 1.7 1.3 1.3 2.1
prr (kHz) 2.6 2.6 2.6 5.6 1 5.6 0.5 5.6 2.1 5.6 1
srr (Hz) 53 - 53 114 9 46 4 46 - - -
Output beam dimension ( || ) (mm)b 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 3.2
Output beam dimension ( | ) (mm)b 9.1 9.1 9.1 9.1 9.1 9.1 9.1 9.1 9.1 9.1 9.1
fawf (MHz) 5.3 5.3 4.3 4 4.9 5 4.9 4.9 5 5 5
APF c (%) - - - - - - - - - - -
AIF d (%) 100 99 82 69 93 71 93 47 53 32 3
Maximum power e (mW) 21.2 21.2 19.1 40 24.3 49.6 9.9 21.3 16.8 17.1 30.3
Iob (mW/cm2) 33.1 33.2 29.8 62.4 38 77.6 15.4 33.3 26.2 26.7 101
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + B+D B+D B+CW
M-CFM M-CFM B-CFM+D B-CFM+D B-
CFM+CW
A-107
M y L a b 5 0 – G E T T I N G S T A R T E D
PA230 (Reference: 960 0165 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM Dp DI CW CnTI
Parameter B M B-TEI M-TEI P I P I
Ð
p_(MPa) 3.3 3.3 3.9 2.8 4.2 3.1 4.5 2.5 3.7 2.3 0.2 1.5
Ispta (mW/cm2) 76 453 211 1297 889 1019 467 1617 2295 2358 1726 54
System settings a SS/SD = SS/SD =
F=3 F=3 F=5 F=4 F=4 F=4 F=6 F=4 2/104mm 2/104mm F=4 F=4
Ip (mm) 52 52 69 58 59 59 83 59 73 73 56 56
wpb6 ( | | ) (mm) 3 3 4.8 3.8 3.6 3.6 7.7 3.6 4.4 4.4 4.2 4.1
wpb6 ( | ) (mm) 6.5 6.5 5 4.5 4.5 4.5 5.3 4.5 4.4 4.4 5.4 4.7
prr (kHz) 2 2 2 5.6 2.8 5.6 0.5 5.6 2.1 5.6 1 5.6
srr (Hz) 45 - 49 125 26 53 - - - - - 66
Output beam dimension ( || ) (mm)b 13.4 13.4 17.9 15.8 15.8 15.8 19.9 15.8 17.9 17.9 9.5 15.8
Output beam dimension ( | ) (mm)b 14 14 14 14 14 14 14 14 14 14 14 14
fawf (MHz) 2.3 2.3 2.1 2.1 2.3 2.3 2.3 2.3 2.4 2.4 2.5 1.8
APF c (%) - - - - - - - - - - - -
AIF d (%) 100 100 117 83 124 93 134 74 111 69 7 43
Maximum power e (mW) 91.6 91.6 293.9 322.5 398.3 448.1 107.7 215.9 330.4 339.4 244.8 134.4
Iob (mW/cm2) 48.7 48.7 117.6 145.9 180.2 202.7 38.7 97.7 132.1 135.8 184.1 60.8
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + B+D B+D B+CW
M-CFM M-CFM B-CFM+D B-CFM+D B-
CFM+CW
A-108
M y L a b 5 0 – G E T T I N G S T A R T E D
PA121 (Reference: 960 0151 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM Dp DI CW
Parameter B M B-TEI M-TEI P I P I
Ð
p_(MPa) 3.5 3.5 2.4 1.6 5.2 3.8 6.3 3 4.5 2.2 0.2
Ispta (mW/cm2) 60 330 79 461 436 616 354 1546 1730 1914 1587
System settings a SS/SD = SS/SD =
F=6 F=6 F=6 F=6 F=5 F=3 F=8 F=5 2/97mm 2/97mm F=6
Ip (mm) 60 60 61 60 55 28 71 54 61 61 69
wpb6 ( | | ) (mm) 3.9 3.9 3.9 3.9 3 2.2 6.6 3.3 3.3 3.5 4.7
wpb6 ( | ) (mm) 7.7 7.7 6.3 6.8 8 10.4 6.9 7.5 7.1 6.1 5.9
prr (kHz) 2.6 2.6 2.6 5.6 2.8 5.6 0.5 5.6 2.1 5.6 1
srr (Hz) 58 - 58 125 28 56 5 56 - - -
Output beam dimension ( || ) (mm)b 14.1 14.1 14.1 14.1 12.9 9.4 16.7 12.9 14.1 14.1 8.1
Output beam dimension ( | ) (mm)b 13 13 13 13 13 13 13 13 13 13 13
fawf (MHz) 3.1 3.1 2.2 2.2 3 3.3 3.1 2.6 3.3 2.5 3.3
APF c (%) - - - - - - - - - - -
AIF d (%) 100 100 68 46 147 106 176 84 127 62 6
Maximum power e (mW) 107.5 107.5 131.5 141.3 246.2 269.7 81.7 237.8 248.5 259.3 237.2
Iob (mW/cm2) 58.7 58.7 71.9 77.2 147.4 219.3 37.6 142.4 135.8 141.7 223.8
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + B+D B+D B+CW
M-CFM M-CFM B-CFM+D B-CFM+D B-
CFM+CW
A-109
M y L a b 5 0 – G E T T I N G S T A R T E D
PA122 (Reference: 960 0152 000)
ModeÎ Imaging Imaging BCFM BCFM MCFM MCFM Dp DI CW
Parameter B M P I P I
Ð
p_(MPa) 4 4 6.2 3.7 6.3 4.2 6 6 0.3
Ispta (mW/cm2) 68 363 396 751 291 1404 2237 2237 3005
System settings a SS/SD = SS/SD =
F=6 F=6 F=8 F=8 F=8 F=6 2/61mm 2/61mm F=5
Ip (mm) 41 41 44 44 44 39 40 40 47
wpb6 ( | | ) (mm) 2.5 2.5 4.1 3.6 4.1 2.3 2.1 2.1 2.6
wpb6 ( | ) (mm) 4.7 4.7 4 3.2 4 4.4 4.2 4.2 2.4
prr (kHz) 2.6 2.6 1.4 5.6 0.5 5.6 2.1 2.1 1
srr (Hz) 58 - 15 59 5 63 - - -
Output beam dimension ( || ) (mm)b 9.2 9.2 10.7 10.7 10.7 9.2 9.2 9.2 6.7
Output beam dimension ( | ) (mm)b 10 10 10 10 10 10 10 10 10
fawf (MHz) 4.4 4.4 4.3 3.5 4.3 4.4 4.8 4.8 5
APF c (%) - - - - - - - - -
AIF d (%) 100 100 157 92 159 106 151 151 7
Maximum power e (mW) 48.8 48.8 69.2 138.6 24.5 95.3 132.1 132.1 130.3
Iob (mW/cm2) 52.8 52.8 64.8 129.7 23 103.2 143 143 194.4
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B-CFM + B-CFM + B+D B+D B+CW
M-CFM M-CFM B-CFM+D B-CFM+D B-
CFM+CW
A-110
M y L a b 5 0 – G E T T I N G S T A R T E D
PA023 (Reference: 960 0153 000)
ModeÎ Imaging Imaging BCFM BCFM MCFM MCFM Dp DI CW
Parameter B M P I P I
Ð
p_(MPa) 4.5 4.4 5.7 4.1 6.2 3.5 4.4 4.3 0.2
Ispta (mW/cm2) 83 336 1115 1254 296 1206 1388 1629 1509
System settings a SS/SD = SS/SD =
F=6 F=5 F=6 F=7 F=7 F=6 2/29mm 2/42mm F=7
Ip (mm) 23 20 22 24 24 22 24 27 23
wpb6 ( | | ) (mm) 2 1.6 1.9 2.7 2.7 1.9 1.6 1.7 1.8
wpb6 ( | ) (mm) 1.5 2.3 1.6 1.5 1.5 1.6 1.7 1.6 1.7
prr (kHz) 2.6 2.6 2.8 5.6 0.5 5.6 2.1 2.1 1
srr (Hz) 58 - 32 63 6 63 - - -
Output beam dimension ( || ) (mm)b 6.1 5.5 6.1 6.7 6.7 6.1 5.5 6.1 5.6
Output beam dimension ( | ) (mm)b 6 6 6 6 6 6 6 6 6
fawf (MHz) 6.4 6.5 5.2 5.1 5.3 5.4 5.2 5.1 5
APF c (%) - - - - - - - - -
AIF d (%) 100 98 128 91 138 78 97 96 5
Maximum power e (mW) 13.7 12 51.4 62.4 8.2 27.1 28 31 36.7
Iob (mW/cm2) 37.4 36.4 140.4 155.2 20.3 74 85 84.8 107.9
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B-CFM + B-CFM + B+D B+D B+CW
M-CFM M-CFM B-CFM+D B-CFM+D B-
CFM+CW
A-111
M y L a b 5 0 – G E T T I N G S T A R T E D
2CW (Reference: 960 0125 000)
ModeÎ CW
Parameter
Ð
p_(MPa) 0.2
Ispta (mW/cm2) 1291
System settings a F=1
Ip (mm) 33
wpb6 ( | | ) (mm) 4.8
wpb6 ( | ) (mm) 3.9
prr (kHz) 1
srr (Hz) -
Output beam dimension ( || ) (mm)b 4.8
Output beam dimension ( | ) (mm)b 3.9
fawf (MHz) 2
APF c (%) -
AIF d (%) 1
Maximum power e (mW) 150.2
Iob (mW/cm2) 214.6
Power-up Mode N/A
Initialization mode B
Acoustic output freeze Yes
Itt (mm) -
Its (mm) Contact
Inclusive modes B+CW
B-
CFM+CW
A-112
M y L a b 5 0 – G E T T I N G S T A R T E D
5CW (Reference: 960 0126 000)
ModeÎ CW
Parameter
Ð
p_(MPa) 0.2
Ispta (mW/cm2) 923
System settings a F=1
Ip (mm) 6
wpb6 ( | | ) (mm) 2.4
wpb6 ( | ) (mm) 3.5
prr (kHz) 1
srr (Hz) -
Output beam dimension ( || ) (mm)b 2.4
Output beam dimension ( | ) (mm)b 3.5
fawf (MHz) 5
APF c (%) -
AIF d (%) 1
Maximum power e (mW) 42.3
Iob (mW/cm2) 302.4
Power-up Mode N/A
Initialization mode B
Acoustic output freeze Yes
Itt (mm) -
Its (mm) Contact
Inclusive modes B+CW
B-
CFM+CW
A-113
M y L a b 5 0 – G E T T I N G S T A R T E D
CA430 (Reference: 960 0169 000)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM D+BCFM DI CnTI
Parameter B M B-TEI M-TEI P I P I p
Ð
p_(MPa) 2.7 2.7 3.1 3 3.6 3.6 3.5 3.5 3.5 3.2 1
Ispta (mW/cm2) 104 724 170 1015 520 520 1413 1413 667 1428 36
System settings a SS/SD =
F=4 F=4 F=8 F=7 F=7 F=7 F=7 F=7 F=8 2/117mm F=7
Ip (mm) 30 30 49 42 49 49 49 49 50 49 38
wpb6 ( | | ) (mm) 3.5 3.5 5.9 6.2 5.8 5.8 5.8 5.8 6.9 6.2 7.3
wpb6 ( | ) (mm) 3.5 3.5 4.5 4.1 3.9 3.9 3.9 3.9 3.7 3.7 4.3
prr (kHz) 5.6 5.6 4.2 4.8 4.2 4.2 4.2 4.2 4.2 2.1 4.8
srr (Hz) 80 - 60 68 41 41 41 41 40 41 68
Output beam dimension ( || ) (mm)b 7.8 7.8 12.6 12 12 12 12 12 12.6 12 12
Output beam dimension ( | ) (mm)b 12 12 12 12 12 12 12 12 12 12 12
fawf (MHz) 2.1 2.1 1.9 1.9 2.3 2.3 2.2 2.2 2.2 2.4 1.7
APF c (%) - - - - - - - - - - -
AIF d (%) 100 100 115 110 132 132 126 126 127 118 38
Maximum power e (mW) 109.5 109.5 265.6 290.2 206.7 206.7 200.8 200.8 139.6 199.4 54.3
Iob (mW/cm2) 116.5 116.4 175.9 201.5 143.5 143.5 139.5 139.5 92.4 138.4 37.7
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + D B+D
M-CFM M-CFM B+D B-CFM+D
A-114
M y L a b 5 0 – G E T T I N G S T A R T E D
CA1421 (Reference: 97154411395)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM D+BCFM DI
Parameter B M B-TEI M-TEI P I P I p
Ð
p_(MPa) 3.8 3.8 3.5 3.1 4.4 3 4.1 3.1 3.8 2.4
Ispta (mW/cm2) 21 201 58 1081 565 717 240 1365 1004 1390
System settings a SS/SD =
F=6 F=6 F=6 F=6 F=6 F=8 F=5 F=8 F=7 2/134mm
Ip (mm) 51 51 42 42 42 54 39 54 48 54
wpb6 ( | | ) (mm) 3.4 3.4 4.2 4.2 4.6 7.5 3.5 7.5 6.5 7.5
wpb6 ( | ) (mm) 2.2 2.2 3.1 3.1 2.9 3.1 3.5 3.1 2.9 3.1
prr (kHz) 2 2 2 5.6 2.8 4.8 0.5 4.8 4.2 4.2
srr (Hz) 27 - 27 75 23 43 4 43 46 -
Output beam dimension ( || ) (mm)b 10.8 10.8 10.8 10.8 10.8 12.6 9.6 12.6 12 12.6
Output beam dimension ( | ) (mm)b 12 12 12 12 12 12 12 12 12 12
fawf (MHz) 3.5 3.5 2.5 2.4 2.8 2.8 2.8 2.8 2.8 2.8
APF c (%) - - - - - - - - - -
AIF d (%) 100 100 93 81 114 78 108 82 100 64
Maximum power e (mW) 18.8 18.8 73 197.4 205.2 245.5 19.8 202.7 219.7 206.4
Iob (mW/cm2) 14.5 14.5 56.3 152.3 158.4 162.4 17.2 134.1 152.5 136.5
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + D B+D
M-CFM M-CFM B+D B-CFM+D
A-115
M y L a b 5 0 – G E T T I N G S T A R T E D
E8-5R10P (Reference: 97154410504)
ModeÎ Imaging Imaging Imaging Imaging BCFM BCFM MCFM MCFM Dp DI
Parameter B M B-TEI M-TEI P I P I
Ð
p_(MPa) 6.2 6.2 5 4.9 6.9 4.4 6.9 4.1 5.2 3.2
Ispta (mW/cm2) 101 530 70 541 785 851 315 1248 1364 1377
System settings a SS/SD = SS/SD =
F=7 F=7 F=8 F=8 F=8 F=7 F=5 F=5 2/31mm 2/31mm
Ip (mm) 24 24 28 28 25 24 23 23 23 23
wpb6 ( | | ) (mm) 2.4 2.4 2.6 2.6 2.7 2.3 1.8 1.8 1.8 1.8
wpb6 ( | ) (mm) 1.8 1.8 1.4 1.4 1.4 1.5 1.9 1.9 1.9 1.9
prr (kHz) 3.9 3.9 3.9 5.6 2.1 5.6 0.5 5.6 2.1 5.6
srr (Hz) 68 - 68 98 21 57 5 57 - -
Output beam dimension ( || ) (mm)b 5.3 5.3 5.7 5.7 5.7 5.3 4.5 4.5 4.5 4.5
Output beam dimension ( | ) (mm)b 7 7 7 7 7 7 7 7 7 7
fawf (MHz) 5.5 5.5 6.9 6.9 6.4 6.4 6.1 6.1 6.5 6.5
APF c (%) - - - - - - - - - -
AIF d (%) 100 100 81 80 112 72 112 67 84 52
Maximum power e (mW) 28 27.9 19 26.4 47.8 50.8 7.7 30.6 33.5 33.8
Iob (mW/cm2) 75.2 74.9 47.4 65.6 118.9 136.2 24.5 97 106 107.1
Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Initialization mode B B B B B B B B B B
Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Itt (mm) - - - - - - - - - -
Its (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact
Inclusive modes B+M B+M B-CFM + B-CFM + B+D B+D
M-CFM M-CFM B-CFM+D B-CFM+D
A-116
ESAOTE S.p.A.
Rev. G
June 2007
OPERATOR MANUAL
8300375000
Introduction
This manual provides information about the probes and consumables that can be used
with the Esaote MyLab devices. The manual is divided into the following chapters:
i
Characteristics and Components...................................................................................................6-1
Examination Safety .......................................................................................................................6-2
Before the Examination ............................................................................................................6-2
During the Examination ............................................................................................................6-3
At the End of the Examination..................................................................................................6-4
Preparation of the Laparoscopic Probe .........................................................................................6-4
7 - Needle Guide Kits .................................................................................................................7-1
Examination Safety .......................................................................................................................7-2
Before the Examination ............................................................................................................7-2
During the Examination ............................................................................................................7-2
At the End of the Examination..................................................................................................7-3
Mounting the Needle Guide for LA and CA Probes.....................................................................7-3
Disposable Biopsy Kit for CA1421 Probe................................................................................7-4
Mounting the Needle Guide for CAB411A Probes ......................................................................7-5
Mounting the Endocavity Probe Needle Guide ............................................................................7-6
EC123 Endocavity Probe ..........................................................................................................7-6
E8-5 Endocavity Probe .............................................................................................................7-7
Mounting the Trans-rectal Probe Needle Guide ...........................................................................7-8
Mounting the Intraoperative Probe Needle Guide ........................................................................7-9
Kit assembling...........................................................................................................................7-9
8 - Accessories and Consumables ............................................................................................8-1
ECG Cable ....................................................................................................................................8-1
Checking the ECG Cable ..............................................................................................................8-1
Cleaning and Disinfecting the ECG Cable ...................................................................................8-1
Stand Off for Linear Probes ..........................................................................................................8-2
Gel.................................................................................................................................................8-3
Sheaths ..........................................................................................................................................8-4
Accessory Kits for Transesophageal Probes.................................................................................8-4
Appendix A - MyLab Probes ....................................................................................................A-1
Phased Array Probes ....................................................................................................................A-1
Linear Probes ...............................................................................................................................A-1
Convex Probes .............................................................................................................................A-2
Specialty Probes...........................................................................................................................A-2
Doppler Probes.............................................................................................................................A-3
Appendix B - Cables and Consumables...................................................................................B-1
ECG Cables..................................................................................................................................B-1
Recommended Consumables .......................................................................................................B-1
Convex Probes .........................................................................................................................B-2
Linear Probes ...........................................................................................................................B-3
Phased Array Probes ................................................................................................................B-3
Specialty Probes.......................................................................................................................B-4
Doppler Probes.........................................................................................................................B-4
Needle Guides ..........................................................................................................................B-5
Manufacturers of Recommended Agents.................................................................................B-6
Appendix C - Probes Electrical Safety.....................................................................................C-1
ii
1
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Chapter
1 - Care of Transducers
W A R N I N G S Do not use a probe if any of the above listed events occur until it has been
established if any electrical damage to the probe has occurred by measuring
the current leakage (see Appendix C for further details). Contact the Esaote
Service Representative.
Do not tug the probe cable or bend it. If the probes are carried around on a
trolley, make sure that the wheels do not roll over the cable.
1-1
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Transducer Controls
Non-invasive Transducers
Non-invasive transducers are intended to be used on the external parts of the body
only.
• The housing is intact. If cracks or breaks are found, have the probe
repaired immediately by contacting an ESAOTE technician.
• The lens does not have any irregularities or is not broken. If any breaks
are found on the scanning windows, do not use the probe again and
have it repaired.
• The probe cable is not broken or damaged. If any damage is found, do
not use the probe again and have it repaired.
• The connector pins are not bent. If the pins are damaged, do not use
the probe and have it repaired.
Breaks to the probe casing or to the cable could result in risks to electrical
W A R N I N G
safety.
Do not use a probe if it has been dropped. A leakage current test (see
Appendix C for further details) must be performed prior to re-use to ensure
that no electrical damage to the probe has occurred.
1-2
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Do not try to dismantle the probe; any attempt to dismantle the probe may
C A U T I O N
damage it and will void the warranty.
• Do not touch the lens at the end of the probe Never exert force on
the lens
• The connector is not waterproof and should always be kept dry. The
control unit, although waterproof, should not be unnecessarily
immersed.
After use, clean and/or disinfect the probe as specified in this manual.
Invasive Transducers
Invasive transducers penetrate the patient’s body through an orifice or through the
surface of the body.
• Perform a manual and visual check to ensure that there are no holes,
bulges, tears or dents along the entire surface of the probe.
• Perform a manual and visual check of the endoscope while bending
the tip in all possible directions; deflection must function according to
characteristics and the guides must not protrude during these
movements.
• Check that the deflection mechanism functions in both modes (free or
with friction).
• Check the cable manually and visually; there must be no cuts or
irregularities.
• Check that the connector pins are not bent. If the pins are damaged,
do not use the probe and have it repaired.
Breaks in the probe casing or in the cable could expose the patient and/or
W A R N I N G
the operator to an electrical safety risk.
Do not use a probe if it has been dropped. A leakage current test (see
Appendix C for further details) must be performed prior to re-use to ensure
that no electrical damage to the probe has occurred.
In case of incorrect operation of the flexion, do not use the probe and call
Esaote Service Assistance.
1-3
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Do not try to dismantle the probe; any attempt to dismantle the probe may
C A U T I O N
damage it and will void the warranty.
• Do not touch the lens at the front of the probe. Never exert force on
the lens.
• The connector is not waterproof and should always be kept dry.
• Before inserting the probe, do not rub or spray the tip of the probe
with an anesthetic agent..
• When not in use, store the probe as specified in the next paragraph.
After use, clean and disinfect the probe as specified in this manual.
• Perform both a visual and manual check to ensure that there are no
holes, bulges, abrasions or dents.
• Perform a visual and manual check of the probe cable; cuts or holes in
the cable may jeopardize electrical safety.
• The connector pins are not bent. If the pins are damaged, do not use
the probe and have it repaired.
Breaks in the probe casing or in the cable could expose the patient and/or
W A R N I N G
operator to an electrical safety risk.
Do not use a probe if it has been dropped. A leakage current test (see
Appendix C for further details) must be performed prior to re-use to ensure
that no electrical damage to the probe has occurred.
Do not attempt to dismantle the probe; any attempt to dismantle the probe
C A U T I O N
may result in damage to the probe and will void the warranty and could
compromise its safety.
1-4
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• Do not touch the lens at the front of the probe. Never exert force on
the lens.
• The connector is not waterproof and should always be kept dry.
After use, clean and disinfect the probe as specified in this manual.
• Perform a manual and visual check to ensure that there are no holes,
bulges, tears or dents along the entire surface of the probe.
• Check the cable manually and visually; there must be no cuts or
irregularities.
• The connector pins are not bent. If the pins are damaged, do not use
the probe and have it repaired.
• When not in use, store the probe as specified in the next paragraph.
Breaks in the probe casing or in the cable could expose the patient and/or
W A R N I N G
the operator to an electrical safety risk.
Do not use a probe if it has been dropped. A leakage current test (see
Appendix C for further details) must be performed prior to re-use to ensure
that no electrical damage to the probe has occurred.
Do not try to dismantle the probe; any attempt to dismantle the probe may
C A U T I O N
damage it and will void the warranty.
• Do not touch the lens at the front of the probe. Never exert force on
the lens.
• The connector is not waterproof and should always be kept dry.
• When not in use, store the probe in its case.
After use, clean and sterilize the probe as specified in this manual.
1-5
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• Perform a manual and visual check to ensure that there are no holes,
bulges, tears or dents along the entire surface of the probe.
• Perform a manual and visual check of the endoscope while bending
the tip in all possible directions; deflection must function according to
characteristics and the guides must not protrude during these
movements.
• Check the cable manually and visually; there must be no cuts or
irregularities.
• The connector pins are not bent. If the pins are damaged, do not use
the probe and have it repaired.
Breaks in the probe casing or in the cable could expose the patient and/or
W A R N I N G
the operator to an electrical safety risk.
Do not use a probe if it has been dropped. A leakage current test (see
Appendix C for further details) must be performed prior to re-use to ensure
that no electrical damage to the probe has occurred.
In case of incorrect operation of the flexion, do not use the probe and call
Esaote Service Assistance.
Do not try to dismantle the probe; any attempt to dismantle the probe may
C A U T I O N
damage it and will annul the guarantee.
• Do not touch the lens at the front of the probe. Never exert force on
the lens.
• The connector is not waterproof and should always be kept dry.
• When not in use, store the probe in its case.
After use, clean and sterilize the probe as specified in this manual.
1-6
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• Wall-mounted supports
• A storage drawer that is large enough to house the endoscope, bending
it as little as possible
Storing and Protecting the Endocavity Probe
The probe must always be cleaned following the instructions provided in the next
chapter. When not in use, the transducer must be stored in the special probes slot
on the machine. If all the available slots are full, place the probe in its case.
For long-term storage, check that the environmental requirements indicated on the
label of the case are observed.
Always use the original case to store the transesophageal probe. The special
C A U T I O N
shape of this case prevents damage to the gastroscope due to excessive
bending.
1-7
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• The socket is not bent. Do not use the socket if it has been damaged.
• The needle guide is not bent. Do not use the guide if it has been
damaged.
1-8
2
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Chapter
2 - Cleaning and
Disinfecting
Transducers and Biopsy
Kits
Transesophageal and Cleaning and Before the first use and after
Semi-critical[2]
Endocavity probes Disinfection each exam.
Intraoperative and
Cleaning and Before the first use and after
Laparoscopic probes Critical[3]
Sterilization each exam.
Needle Guide kits Cleaning and Before the first use and after
Critical[3]
Sterilization each exam.
[1] The application is considered non-critical when the device is used on intact skin.
[2] The application is considered semi-critical when the device is used on the mucous membranes.
[3] The application is considered critical when the device comes into contact with blood or
compromised tissue.
Make sure that patients who are allergic to latex are identified before each
W A R N I N G
examination. Serious allergic reactions to latex have been reported; the
Operator should be prepared to handle such reactions.
2-1
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
ESAOTE recommends disinfecting the probe, if the probe has not been
used for an extended period.
Note
Agents
Refer to Appendix B for a list of recommended cleaning, disinfection and
sterilization agents.
Personnel should adopt all necessary protective measures during the probe
cleaning, disinfection and sterilization processes (i.e. gloves, protective
glasses ….).
Never attempt to clean or disinfect the probes while they are connected to
the unit.
2-2
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
The disinfection procedures described in this paragraph apply to all probes used in
non-critical applications. The application is considered non critical when the device
is used on intact skin. Low-level disinfection is sufficient for these applications.
The probes can be disinfected using the recommended agents, following the
manufacturer’s instructions.
Do not soak the probe in the disinfection solution for periods beyond the
time required to achieve a disinfection.
Do not try to sterilize probes using the autoclave, ultra-violet rays, gamma
C A U T I O N
rays or gas, steam or heat sterilization techniques. These sterilization
methods can permanently damage the probe. Any damage to the probe
caused by substances or methods not approved by ESAOTE is not covered
by the guarantee.
2-3
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• Extract the probe, rinse it with sterile water and clean the probe handle
and cable using the recommended agents or with a mild detergent
solution.
• Dry the probe carefully using a soft cloth or leave it to air dry for at
least 30 minutes.
Do not leave the probe immersed in the disinfectant for longer than the
W A R N I N G
time indicated by the manufacturer for high-level disinfection.
Do not immerse the entire body of the probe. The probe is not waterproof
and immersion may compromise the electrical safety characteristics (see
Appendix A for Maximum Immersion Level).
• Extract the probe, rinse it with sterile water and clean the probe handle
and cable with a soft cloth dampened with a mild detergent solution.
• Dry the probe carefully using a soft cloth or leave it to air dry for at
least 30 minutes.
2-4
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
For information on how to store disinfected parts, refer to the locally applicable
procedures.
Personnel should adopt all necessary protective measures during the probe
W A R N I N G
cleaning, disinfection and sterilization processes (i.e. gloves, protective
glasses ….).
The probe, eventual accessories and the kit must be sterilized before it is used for
the first time. They must be cleaned and sterilized after every examination.
Esaote recommends • Dismantle the kit or the accessories from the probe.
sterilizing the probe
and the kit before • Clean the kit, the accessories or the probe carefully with mild soap.
they are used for the
first time after
prolonged storage
• Follow the instructions of the manufacturer of the sterilization agent.
periods.
Note
The material used for needle guide kits can undergo all the
sterilization methods used for surgical instruments.
The type of tissue the transducer comes into contact with establishes the
disinfection level.
For information on how to store sterilized parts, refer to the locally applicable
procedures.
2-5
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Clean the attachment with a mild soap solution; make sure that no residuals are
left.
Sterilization Place the attachment in an appropriate bag and use Ethylene Oxide Gas, at
Procedure following conditions:
2-6
3
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Chapter
3 - The
Transesophageal Probe
The transesophageal probes (TEE022 and TE122) is a Type BF part. The probe
must be physically intact and the system correctly grounded for the electrical safety
of the patient and operator.
Read the Safety and Standards Manual carefully: all the safety
SS characteristics, cautions and warnings listed also apply to the use of this
probe.
Mobile configurations are fitted with insulated supply sockets for supplying
documentation systems without increasing the current leakage. Incorrect
connections or failure to use insulated sockets may compromise electrical
safety.
In case of doubts about the protective earth connection, DO NOT use the
probe and contact ESAOTE immediately.
These probes are equipped with a temperature sensor; MyLab models are designed
to use these sensor thermal data to prevent probe tip overheating.
2. Probe handle with the probe tip deflection control and the transducer
rotational knob
3-1
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
3. Locking device
4
1 5
Examination Safety
The user must know The transesophageal examination is to be carried out by operators who
how to recognize have been specially trained to insert the probe and interpret the images.
contraindications to
the examination and
Carefully review current medical provisions and follow their precautions and
any possible recommendations concerning the preparation and positioning of the patient, probe
complications, such as insertion and manipulation techniques.
tip buckling.
3-2
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Be familiar with the mechanical and thermal indices display and the ALARA
SS principle (As Low As Reasonably Achievable) before using the probe. The patient
must be exposed to ultrasound for as short a time as possible and only for as long
as it takes to achieve the diagnostic information.
Before probe use, check to be sure that the probe name shown on the
W A R N I N G
monitor is correct.
• Do not leave the probe against the esophagus wall for prolonged
periods.
• Cover the probe handle with a disposable cloth during examinations in
which the presence of pathogenic micro-organisms is suspected.
• If it is necessary to use the defibrillator, disconnect and remove the
probe from the patient.
Electric scalpels used
during the TEE Electric scalpels and other devices that introduce radio frequency or electro-
examination interfere magnetic current fields into the patient interfere with ultrasound images.
with the 2D and
make it impossible to
use Doppler
High frequency signals used by ultrasound can interfere with the functioning of
procedures. pacemakers.
3-3
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
While using the system in combination with high frequency devices (like electro-
surgical units), be aware that a failure in the surgical device or a damage to the
transducer lens can cause electro-surgical currents that can burn the patient.
Thoroughly check the system and the probe before applying HF surgical currents
to the patient. Disconnect the probe when not imaging.
Temperature Control
Transesophageal probes are equipped with a temperature sensor, to provide
AO continuous feed-back on the temperature of the probe tip; the ultrasound scanner
The Advanced
Operation manual constantly samples and displays the probe temperature.
indicates specific
in
information Once the probe is connected, the temperature is displayed on the screen.
applicable to your
MyLab model. To ensure patient safety, the ultrasound scanner “allows” a maximum temperature
of 42.5°C (108.5°F); if the probe reaches this limit, the system automatically de-
activates and displays a warning message.
As soon as the temperature goes down below the thermal limit, the message
disappears and the probe starts working again. The Operator should either wait for
the probe to cool down or interrupt the procedure and remove the probe from the
patient.
How to Minimize In normal conditions, the probe does not reach the thermal limit; the limit may be
Probe Heating reached in patients with fever or due to breakage of the thermal sensor. A list of
recommendations follows to prevent the probe from over-heating:
3-4
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• The CFM mode is the greatest heat “generator”; limit the use of the
CFM as much as possible in patients with a high body temperature.
• Trans-gastric projections reduce heat dissipation; repositioning the
probe in the esophagus may make the probe cool down quickly.
Note
See Chapter on The use of latex transducer covers is strongly recommended, along with a bite
Consumables for guard to protect the probe shaft. These items are available as accessory kits, which
selecting these
accessory kits
also contain items that facilitate placement of the probe cover on the transducer.
• Place the tip of the probe in a straight position and release it.
• Completely unroll the sheath along the transducer body, making it adhere,
so as to avoid air pockets.
Transducer Orientation
The probe handle wheels can be used to rotate the transducer inside the tip or to
change the tip position.
Transducer The rotation of the transducer is controlled by the smallest knob and is adjustable
Rotation from 0° to 180°. In the zero position, the transducer will scan the transversal plane.
The zero, 90° and 180° positions are marked on the knob.
3-5
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Tip Position The probe tip can be oriented to optimize tissue contact. The articulation of the
flexibile part of the probe is controlled by the largest knob; up- and back-wards
adjsutments are feasable:
The zero position is marked on the knob. This knob can be locked into position by
engaging the locking device, located next to the knob. This locking device has two
color coded positions: on red, the tip is locked, on grey the tip is loose.
During probe
insertion, make sure
that the tip is
unlocked (grey
locking device)
3-6
4
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Chapter
4 - The Endocavity
Probes
The endocavity (EC123 and E8-5) and transrectal (TRT33) probes are Type BF
parts. As per directive EN60601-1, the probe must be physically intact and the
system correctly grounded for the electrical safety of the patient and operator.
Read the Safety and Standards Manual carefully: all the safety
SS characteristics, cautions and warnings listed also apply to the use of this
probe.
Mobile configurations are fitted with insulated supply sockets for supplying
documentation systems without increasing the leakage current. Incorrect
connections or failure to use insulated sockets may compromise electrical
safety.
In case of doubts about the protective earth connection, DO NOT use the
probe and contact ESAOTE immediately.
The TRT33 incorporates both a convex transducer and a linear transducer for
longitudinal and transversal scanning.
The EC123 and TRT33 probes are delivered with the following accessories:
• Storage case
• Tubing kit (60 cc syringe with IV extension tubing and stopcock)
4-1
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Examination Safety
Endocavity probes must be used by operators who have been specially
trained to insert the probe and interpret the images. Carefully review current
medical provisions and follow their precautions and recommendations concerning
the preparation and positioning of the patient, probe insertion and manipulation
techniques.
Note
Make sure that patients who are allergic to latex are identified before each
W A R N I N G
examination. Serious allergic reactions to latex have been reported; the
Operator should be prepared to handle such reactions.
The Operator should be familiar with the mechanical and thermal indices display
SS and the ALARA principle (As Low As Reasonably Achievable) before using the
probe. The patient must be exposed to ultrasound for as short a time as possible
and only for as long as it takes to achieve the diagnostic information.
4-2
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Note
• Completely unroll the sheath along the transducer body, making it adhere,
so as to avoid air pockets.
4-3
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• Cover the part of the probe that can be immersed with the stand-off
cap and attach it with the rubber band provided at about 5 cm. from
the tip; make sure the water intake hole is below the band.
• Fill a 60 cc syringe with sterile water.
• Apply the tap valve to the syringe.
• Connect a section of the IV tube to one end of the tap; the other end
of the IV tube must be inserted into the probe-filling hole.
• Open the tap; inject about 30 cc of water into the probe.
• To eliminate air bubbles, turn the probe upwards holding it by the
Eliminate the air handle; the bubbles will rise towards the water intake hole.
bubbles between the
transducer and the • Suck air back into the syringe; close the tap to remove the syringe and
sheath; air bubbles expel the air.
impede the
transmission of • Repeat this procedure until all the air bubbles have been eliminated.
ultrasound.
• Replace water, without air, back into the syringe and close the valve;
leave the tube and the syringe connected.
• Apply ultrasound examination gel to the tip of the stand-off.
• Cover the portion of the probe that is to be inserted with the
protection cap.
The protective sheaths available on the market often contain latex. Make
W A R N I N G
sure that patients who are allergic to latex are identified before each
examination. Serious allergic reactions to latex have been reported; the
Operator should be prepared to handle such reactions.
• To make insertion easier, apply some lubricating gel to the tip of the
probe.
Once the probe is in the correct position, fill the stand-off with water again. To
optimize image quality, use enough water to ensure that the probe adheres as well
as possible to the rectal wall.
Do not remove the probe from the rectum if the probe tip is still full of water.
4-4
5
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Chapter
5 - The Intraoperative
Probe
The intraoperative probe (IOE323) is a Type BF part. The probe must be physically
intact and the system properly grounded for the electrical safety of the patient and
operator.
SS Read the Safety and Standards Manual carefully: all the safety
characteristics, cautions and warnings listed also apply to the use of this
probe.
Mobile configurations are fitted with insulated supply sockets for supplying
electricity to the systems without increasing the leakage current. Incorrect
connections or failure to use insulated sockets may compromise electrical
safety.
• Storage case
• Handle attachment
• Finger attachment
• Sled attachment
5-1
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• Biopsy attachment.
The IOE323 probe is designed to form an angle of 45° between the head, which
houses the transducer and the terminal portion where the cable is connected.
The terminal portion of the probe has a square shape to accommodate accessories
available for use with the probe, offering maximum comfort during surgical
ultrasonography.
The probe accessories are shaped in a manner to prevent rotation and to improve
patient safety.
Probe’s Transducer
45° angle
Probe’s Cable
Examination Safety
The intraoperative examination is to be carried out by operators who have
been specially trained to use the probe and interpret the images. Carefully
review current medical provisions and follow their precautions and
recommendations concerning the preparation and positioning of the patient, probe
insertion and manipulation techniques.
Do not use the intraoperative probe in direct contact with the heart, the
W A R N I N G
central circulatory system and the central nervous system.
• Perform a manual and visual inspection of the entire probe prior to use
(see Chapter 2 of this manual). DO NOT use the probe if it has been
damaged or if damage is suspected.
5-2
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• Use protective sheaths during the examination. These sheaths are usually
composed of latex (natural rubber).
Make sure that patients who are allergic to latex are identified before each
W A R N I N G examination. Serious allergic reactions to latex have been reported; the
Operator should be prepared to handle such reactions.
Note
The operator must be familiar with the mechanical and thermal indices display and
SS the ALARA principle (As Low As Reasonably Achievable) before using the probe.
The patient must be exposed to ultrasound for as short a time as possible and only
for as long as necessary to achieve the diagnostic information.
Electric scalpels used Electric scalpels and other devices that introduce radio frequency or electro-
during the IOE magnetic current fields into the patient interfere with ultrasound images.
examination interfere
with the 2D and While using the system in combination with high frequency devices (like electro-
make it impossible to
use Doppler
surgical units), be aware that a failure in the surgical device or a damage to the
procedures. transducer lens can cause electro-surgical currents that can burn the patient.
Thoroughly check the system and the probe before applying HF surgical currents
to the patient. Disconnect the probe when not imaging.
5-3
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Note
Note
• Completely unroll the sheath along the transducer body, making it adhere,
so as to avoid air pockets.
5-4
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Handle
The handle attachment, is inclined 30 degrees, and can be placed on the probe in
attachment four different positions to form four different shapes (profiles) A, B, C and D as
shown below and on the following pages:
Probe’s Transducer
4 facets at 90°
Probe’s Holder
30° inclination
5-5
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Probe’s Transducer
Probe’s
Transducer
A B
Probe’s Transducer
C D
5-6
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Finger attachment The Finger Attachment allows manipulation of the Intraoperative IOE323 probe
for use with only two fingers.
The 4 facets, at 90 degrees, allow the user to obtain four different insertion
methods with the probe.
4 facets @ 90°
finger attachment
finger attachment
transducer
5-7
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Sled attachment The sled attachment has been developed to provide easier manipulation of the
probe during both intraoperative and superficial scanning. The attachment
corresponds to the ergonomics of the probe, and is the same length as the
transducer.
5-8
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
To place the attachment on the probe, follow the procedure described below. The
sequence is also shown in the following design.
2. Rotate the sled attachment around the probe until it is safely in place
between the two lateral extensions of the attachment.
3. Press the transducer inside the holder, hearing a click, to assure secure
and complete insertion.
5-9
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
5-10
6
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Chapter
6 - The Laparoscopic
Probe
The laparoscopic probe (LP323) is a Type BF part. The probe must be physically
intact and the system properly grounded for the electrical safety of the patient and
operator.
Read the Safety and Standards Manual carefully: all the safety
characteristics, cautions and warnings listed also apply to the use of this
probe.
Mobile configurations are fitted with insulated supply sockets for supplying
electricity to the systems without increasing the leakage current. Incorrect
connections or failure to use insulated sockets may compromise electrical
safety.
• Storage case
• Extension tube
6-1
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
LP323 Probe
The LP323 probe has an articulation that allows a double movement of its
extremity in order to position the transducer directly on to the surface of the organ
under evaluation. This movement is adjustable by two control levers located on the
probe handle.
Examination Safety
The laproscopic examination is to be carried out by operators who have
been specially trained to use the probe and interpret the images. Carefully
review current medical provisions and follow their precautions and
recommendations concerning the preparation and positioning of the patient, probe
insertion and manipulation techniques.
Do not use the laparoscopic probe in direct contact with the heart, the
W A R N I N G
central circulatory system and the central nervous system.
• Perform a manual and visual inspection of the entire probe prior to use
(see Chapter 2 of this manual). DO NOT use the probe if it has been
damaged or if damage is suspected.
• Use protective sheaths during the examination. These sheaths are usually
composed of latex (natural rubber).
6-2
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Note
Make sure that patients who are allergic to latex are identified before each
W A R N I N G examination. Serious allergic reactions to latex have been reported; the
Operator should be prepared to handle such reactions.
Be familiar with the mechanical and thermal indices display and the ALARA
SS principle (As Low As Reasonably Achievable) before using the probe. The patient
must be exposed to ultrasound for as short a time as possible and only for as long
as necessary to achieve the diagnostic information.
Before introducing the LP323 probe into the Trocar verify that there is no
W A R N I N G
mechanical play of the tip of the probe.
While inserting the LP323 probe into the Trocar, the tip of the probe should
be in a straight position.
Electric scalpels used Electric scalpels and other devices that introduce radio frequency or electro-
during the LP magnetic current fields into the patient interfere with ultrasound images.
examination interfere
with the 2D and While using the system in combination with high frequency devices (like electro-
make it impossible to
use Doppler
surgical units), be aware that a failure in the surgical device or a damage to the
procedures. transducer lens can cause electro-surgical currents that can burn the patient.
Thoroughly check the system and the probe before applying HF surgical currents
to the patient. Disconnect the probe when not imaging.
6-3
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Note
Note
• Completely unroll the sheath along the transducer body, making it adhere,
so as to avoid air pockets.
6-4
7
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Chapter
ESAOTE supplies a series of optional adaptors for the biopsy needle guide, fitted
with special couplings for connection to the probe. The following table lists the
available kits.
Do not use needle guides other than those described in this manual.
W A R N I N G
ABS421, ABS424, ABS1421, ABS523, ABS621 and ABS15 kits are composed of
stainless steel; the ABS123 and ABS33 needle guide kits are composed of titanium.
Disposable needle In addition to the above mentioned biopsy adaptors, the CA and LA probes are
guides for CA and equipped with four biopsy kits composed of sterilizable mounting brackets and
LA probes
disposable needle guides1. The following table lists the available kits.
7-1
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
The biopsy adaptors must be attached to the probes using the alignment pivots, as
below described. Follow the instructions provided with these kits to properly use
them and to clean, disinfect and sterilize them.
Examination Safety
All safety information related to the use of the needle guide kits is in addition to the
SS safety procedures described for the system and for the probes. Consult your MyLab
“Safety & Standard” manual for additional safety information.
• Handle the biopsy kit and the probe with sterile gloves.
• Perform a visual check of the adaptor and needle guides: do not use
them if any damage or distortion is found.
• Use protective sheaths during the examination. These sheaths are
primarily composed of latex (natural rubber).
Note
Make sure that patients who are allergic to latex are identified before each
W A R N I N G
examination. Serious allergic reactions to latex have been reported; the
Operator should be prepared to handle such a reaction.
7-2
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
The lines displayed on the monitor only provides an indication of the needle
W A R N I N G
direction, according to the selected guide. Pay particular attention to the
ultrasound image during the insertion of the needle into the body and be
sure that the needle always stays within the displayed area.
Before performing the biopsy-test, check for the correct assembly and
positioning of the biopsy kit. Also, check that the insertion angle is equal to
the angle selected via the user interface software.
Needle insertion in a guide with an insertion angle other than that of the
selected angle involves risks to patient safety.
• Connect the kit to the probe, positioning the two alignment pins on
the special notches on the probe.
Note
The guiding device for needle insertion must be on the same probe
side of the LED. The coupling must click into the special notch on
the probe.
7-3
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Note
When using the disposable biopsy adaptors and with the ABS1421,
the coupling device has to be mounted before inserting the protective
cap; this will allow to safely use the same coupling device in different
exams.
Needle
Make sure the bottom cone shaped part (at the bottom of the bracket) is
W A R N I N G
screwed into the indentation at the bottom of the top curved portion of the
probe. If the user does not perform this operation correctly, the insertion
angle can be wrong causing a risk to patient safety.
7-4
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
0°
15°
30
Needles
dimension
The innovative design allows easy removal of the biopsy attachment while the
needle is inserted in the tissue.
Note
7-5
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• Insert the needle guide in one of the three holes formed between the
wings of the bracket paying attention to choose the correct insertion
angle.
The figure shows an
example of how the
needle guide is
assembled on the
CAB411A..
7-6
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• Connect the kit to the probe, positioning the two alignment pins on
the special notches on the probe.
Needle
Needle guide
Holder
Needle guide
fixing
Alignment
Hinge
Hinge fixing
7-7
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
The position of the needle-guide is adjustable both longitudinally and along the
depth.
The vertical adjustment allows the user to change the needle depth in the linear
transducer field of view and is performed by sliding the needle guide along the
vertical track. To guarantee the precision of the adjustment, the vertical guide has a
scale in centimeters (1cm to 5cm) corresponding to the depth shown in the
ultrasound image; the needle guide has two notches to indicate each of the two
guides for the supported needles. By rotating the needle guide the user can select
the gauge. The “Needle guide fixing pawl” holds the guide in place.
7-8
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Kit assembling
The ABS15 biopsy kit can only be placed on the probe handle attachment as
shown below.
Check the integrity of the probe and needle guide and assemble the biopsy kit as
follow:
• Once the biopsy kit has been positioned on the handle attachment as
shown in picture 1, insert the biopsy bracket into the grooves on the
handle attachment by sliding the biopsy bracket to the end of the
groove. Attach the bracket with the screw provided.
7-9
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• Choose the needle guide acceptable for the diameter of the needle to
be used and insert it into the bracket.
• Attach the needle guide to the bracket with the screw provided.
• The needle can then be inserted into the hole formed between the
bracket and the attached needle guide.
If necessary, the needle guide attachment can be removed from the handle
attachment without removing the needle.
7-10
8
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Chapter
8 - Accessories and
Consumables
ECG Cable
The leads on the ECG cable supplied by Esaote are equipped with a pliers terminal. Any
button electrode can be used with the ECG cable. We recommend using disposable
Ag/AgCl electrodes. Read the manufacturer’s instructions carefully for correct use of the
electrodes.
ECG Cable Disconnect the cable from the system and check that there are no breaks or slits.
Inspection
Note
Esaote recommends replacing the ECG cable if there are any breaks
or slits.
Never try to clean or disinfect the ECG cable when it is still connected to the unit.
W A R N I N G
Equipment The equipment listed in the following table will be necessary for periodic maintenance
procedures.
8-1
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
• Clean the cable by rubbing it gently with a soft cloth dampened with water
and a mild detergent.
Do not immerse the ECG cable further than the start of the leads. The cable is not
C A U T I O N
waterproof.
• Rub the cable gently with a soft cloth slightly dampened with a mild detergent
solution or alcohol.
• Immerse the ECG cable leads in CIDEX OPA. When using the disinfectant
substance, carefully follow the manufacturer’s instructions.
The stand off can be mounted on all MyLab linear probes with size 4 e 5 cm (LA 4XX and
LA5XX probe families).
8-2
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
To get the desired distance the operator has to fill with water (preferably sterile) or
ultrasound gel the contact pocket equipped with a cock.. The pocket can be filled and
emptied using a syringe which perfectly suits into the cock opening.
During the exam, check that the cock is perfectly closed and correctly mounted on
C A U T I O N
its case, to avoid fluid leaks or air bubbles.
Using the Stand- • Immerse the stand off into water before each use.
Off
• Apply ultrasound gel on the probe.
• Place the stand off on the probe sliding it till some gel comes out from the lower
part of the pocket, on the base of the filling tube.
• Apply ultrasound gel on the stand off (between the contact pocket and the
patient).
When the stand off is not used, it is recommended to store it far from light sources,
C A U T I O N
to avoid early ageing of the rubber.
Cleaning and The stand off is made of natural rubber and can be cleaned with a mild soap. Thoroughly
Disinfecting rinse it with water , expecially after each contact with disinfectant agents.
To dry the stand off, use warm air at 60° or a clean cloth.
Sterilizing Sterilization cam be performed in autoclave at 134°C for 20 minutes, if the contact pocket
doesn’t contain ultrasound gel.
Gel
Transmission gel must always be applied to probes to obtain correct probe-patient contact.
Esaote recommends only using water or glycerine-based ultrasound gel.
Do not use gels containing the substances listed below. The transducer could be
C A U T I O N
damaged if such gels are used.
Substances to Be • acetone
Excluded
• methanol, ethanol, isopropyl alcohol
• mineral oil
• iodine
• glycol
8-3
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
The following table indicates ultrasound gels that have tested compatibility with MyLab.
Product Supplier
Aquasonic® Parker Laboratories, Inc.
Scan® New Jersey, USA
Sheaths
The use of protective sheaths is recommended in all clinical situations where there is a risk
of infection. Specific sheaths are available on the market for most types of Esaote probes.
The sheaths listed below are produced by CIVCO Medical Instruments Inc., Kalona, IA
(USA). Refer to the manufacturer’s instructions for the characteristics and use of the
protective sheaths.
IOE323 Probe The intraoperative probe uses the Esaote sterilized sheath Ref.1000000065.
LP323 Probe TheLaparoscopic probe uses the Esaote sterilized sheath Ref.7900000210.
8-4
A
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Appendix
Appendix A - MyLab
Probes
This chapter provides a list of MyLab probes with their main characteristics; system
GS dependent features are described in your model documentation.
Linear Probes
Probe ID Maximum immersion level
LA522 Up to 3 cm from transducer head
LA532 Up to 3 cm from transducer head
LA523 Up to 3 cm from transducer head
LA424 Up to 3 cm from transducer head
LA435 Up to 3 cm from transducer head
LA923 Up to 3 cm from transducer head
A-1
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Convex Probes
Probe ID Maximum immersion level
CA421 Up to 3 cm from transducer head
CA431 Up to 3 cm from transducer head
CA430 Up to 3 cm from transducer head
CA621 Up to 3 cm from transducer head
CA631 Up to 3 cm from transducer head
CA123 Up to 3 cm from transducer head
CAB411A Up to 4 cm from transducer head
Specialty Probes
Transesophageal
(Adults)
Probe ID TEE022
Technology Phased Array
Imaging plane 0-1800
Maximum immersion level Up to 1 m from transducer head
Probe ID E8-5
Technology Convex Array
Imaging plane Sagittal
Maximum immersion level Up to 25 cm from transducer
head
A-2
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
BiScan Convex
Probe ID BC431
Technology Convex Array
Maximum immersion level Up to 9.5 cm from transducer
head
Doppler Probes
Continuous Wave Probe ID Maximum immersion level
2 CW Up to 6 cm from transducer surface
5 CW Up to 6 cm from transducer surface
A-3
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
A-4
B
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Appendix
Appendix B - Cables
and Consumables
ECG Cables
This chapter provides a list of MyLab ECG cables with their main characteristics;
GS refer to your system documentation for ECG capabilities..
Reference Description
9630028000 3-Leads ECG Cable - IEC Colours
9630028010 3-Leads ECG Cable - AHA Colours
Recommended Consumables
Below is the recommended single use electrodes; the product has been tested for
compatibility with the ESAOTE MyLab systems.
B-1
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Convex Probes
CA123 CA421 CA1421 CA430 CA431 CA621 CA631
Anioxyde 1000 X X X X X S X
Cidex® D D D D D D X
Cidex Activated S S X S S S X
Dialdehyde Solution
Cidex® OPA D D D D D D D
Cidexplus® D/S D/S D/S D/S D/S D/S D/S
Enzol/Cydezime C C C C C C X
Gigasept (10% vol.) D D D D D D X
Gigasept® FF D D D D D D D
Medi-Prep C C C C C C X
Medister S S X S S S X
Metricide® S S S S S S X
Milton X X X X X X C
NuCidex X X X X X S X
OmnicideTM (2.25%) D/S D/S D/S D/S D/S D/S X
Perasafe® X X X X X S X
Sani-cloth Active C C C C C C X
Super Sani-cloth X X X X X X C
Secure HLD X X X X X D/S X
Sporox II X X X X X X D
Steranios D D D D D D X
Transeptic Spray X X X X X X C
T-Spray C C C C C C C
T-Spray II C C C C C C C
Virkon® D D D D D D D
Wavicide-01® D/S D/S D/S D/S D/S D/S D/S
B-2
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Linear Probes
LA424 LA435 LA522 LA523 LA532 LA923
Anioxyde 1000 X X X X X S
Cidex® D D D D D D
Cidex Activated S S S S S S
Dialdehyde Solution
Cidex® OPA D D D D D D
Cidexplus® D/S D/S D/S D/S D/S D/S
Enzol/Cydezime C C C C C C
Gigasept (10% vol.) D D D D D D
Gigasept® FF D D D D D D
Medi-Prep C C C C C C
Medister S S S S S S
Metricide® S S S S S S
NuCidex X X X X X S
OmnicideTM (2.25%) D/S D/S D/S D/S D/S D/S
Perasafe® X X X X X S
Sani-cloth Active C C C C C C
Secure HLD X X X X X D/S
Steranios D D D D D D
T-Spray C C C C C C
T-Spray II C C C C C C
Virkon® D D D D D D
Wavicide-01® D/S D/S D/S D/S D/S D/S
B-3
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Specialty Probes
BC431 CAB411 E8-5 EC123 IOE323 LP323 TEE022 TRT33
TEE122
Alkazyme X C X X X X X X
Anioxyde 1000 X X X X X X X S
Cidex® D D D D D D D D
Cidex Activated X X S X X X X S
Dialdehyde Solution
Cidex® OPA D D D D D D D D
Cidexplus® X D/S D/S D/S X X X D/S
Enzol/Cydezime C C C C C X C C
Ethylene Oxide X S X X X X X X
Gigasept (10% vol.) D D D D D X D D
Gigasept® FF D D D D D X D D
Medi-Prep C X C C C X X C
Medister X S S S S S X S
Metricide® X S S S X X S S
NuCidex X X X X X X X S
OmnicideTM (2.25%) X X D/S D X X D/S D/S
Perasafe® X X X S S S X S
Salvanios X C X X X X X X
Sani-cloth Active C X C C C X X C
Secure HLD X X X D/S D/S D/S X D/S
Steranios X D D X X X D D
STERRAD®100 X S X X S S X X
T-Spray C C C C C C C C
T-Spray II C C C C C C C C
Virkon® D X D D D X D D
Wavicide-01® X D/S D/S D/S X X X D/S
Doppler Probes
2CW 5CW
Cidex® D D
Cidex® OPA D D
Cidexplus® D/S D/S
Enzol/Cydezime C C
Gigasept (10% vol.) D D
Gigasept® FF D D
Medi-Prep C C
Metricide® S S
OmnicideTM (2.25%) D/S D/S
Sani-cloth Active C C
Steranios D D
T-Spray C C
T-Spray II C C
Virkon® D D
Wavicide-01® D/S D/S
B-4
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Needle Guides
ABS421 ABS621 ABS523 ABS424 ABS123 ABS15
Cidex® D D D X D D
Cidex® OPA D D D X D D
Cidexplus® D/S D/S D/S X D/S D/S
Enzol/Cydezime C C C C C C
Gigasept (10% vol.) D D D X D D
Gigasept® FF D D D X D D
Medi-Prep C C C C C C
Metricide® X S S X X S
OmnicideTM (2.25%) D/S D/S D/S X D/S D/S
Perasafe® S S S X S S
Sani-cloth Active C C C C C C
Steam (autoclave) S S S S S S
Steranios D D D X D D
Steris S S S X X X
T-Spray C C C C C C
T-Spray II C C C C C C
Virkon® D D D X D D
Wavicide-01® D/S D/S D/S X D/S D/S
Besides the agents indicated in the table, all compatible sterilization methods for
surgical instruments can be applied to the ABS15, ABS123, ABS424, ABS523,
ABS1421, ABS621 and ABS33B kits.
B-5
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Cidex Activated
Liquid Alkalyne glutaraldehyde solution
Dialdehyde Solution
Advanced Sterilization Products
Cidex® OPA Liquid Ortho-phtalaldehyde USA
(www.sterrad.com/about_asp/locations/index.asp)
Cidexplus® Liquid Glutaraldehyde
Enzol/Cydezime Liquid Enzymatic detergent
NuCidex Liquid Peracetic acid
Low-temperature hydrogen
STERRAD®100 System
peroxide gas plasma
Ethylene Oxide System Ethylene Oxide Various Various manufacturers
OmnicideTM (2.25%) Liquid Glutaraldehyde USA COTTRELL LTD
Gigasept
Liquid Succindialdehyde Schülke&Mayr GmbH,
(10% vol.) Germany
(www.schuelkemayr..com/int/en/contact/smi044_adresses.htm)
Gigasept® FF Liquid Succindialdehyde
In aqueous solution-hydrogen
Perasafe® Powder Day-Impex Ltd, (http://www.day-
peroxide +peracetic acid UK
impex.co.uk/lab_products.asp)
Virkon® Liquid Potassium peroximonosulphate
Metrex Research Corporation,
MetricideTM Liquid Glutaraldehyde USA
(www.metrex.com/company/contact/index.cfm)
Wavicide-01® Liquid Glutaraldehyde USA Wave Energy Systems INC
Peracetic
Steris System acid+lowtemperature+biocidal
agent
USA STERIS Corporation, (www.steris.com)
Hydrogen peroxide; phosphoric
Secure HLD Liquid
acid
Klenzyme Liquid Enzymatic detergent
In aqueous solution-hydrogen
Medister Powder Italy Euro Trading S.r.l.
peroxide +peracetic acid
Steam
System Steam Various Various manufacturers
(autoclave)
Steranios Liquid Glutaraldehyde
Quaternary ammonium propionate,
Salvanios Powder France Laboratoires Anios, (www.anios.com)
guanidinium acetate
Anioxyde 1000 Liquid Peracetic acid
Professional Disposables International,
Sani-cloth HB Wipes Quaternari ammonium compounds USA
(www.nicepak.com/divisions/pdi/default.asp)
Medi-Prep Wipes 1% cetrimide BP UK Seton
Milton Pharmaceutical Ltd, (www.milton-tm.com/milton-baby-
Milton Liquid Sodium hypochlorite France
hygiene-products-contact.htm) or Laboratoires RIVADIS
IPA, quaternary ammonium
Alkazyme Powder France Alkapharm UK. Ltd, (www.alkapharm.co.uk)
chloride
Sultan Healthcare, Inc.,
Sporox II Liquid Hydrogen peroxide USA
B-6
C
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Appendix
Appendix C - Probes
Electrical Safety
The transesophageal, endocavitary, intraoperative and laparoscopic probes,
produced by Esaote, are classified as Type BF applied parts. To ensure electrical
safety both to the patient and the operator, it is necessary to check the physical
integrity of the probe and to have the system correctly grounded.
Do not use a probe which underwent any kind of shock or whose integrity
W A R N I N G has been compromized (carefully read Chapter 1 of this manual), until its
electrical integrity has been defined by a leakage current measurement.
Contact your local ESAOTE representative.
Note
During the test do not touch either the electrodes or the liquid where the
W A R N I N G
probe is immersed. During the test a high voltage is applied on the
electrodes..
Do not immerse the probe cable or connector into water or other liquids.
Immersion may compromise the electrical safety features. The probe can
C-1
M y L a b – T R A N S D U C E R S A N D C O N S U M A B L E S
Legenda
1: Measuring device
2: Conductivity sensor
3: Probe adapter
4: Water tank filled with Cidex® or saline solution
5: Probe to be examined
C-2
ESAOTE S.p.A.
Rev. B
February 2005
OPERATOR MANUAL
8300372000
Introduction
This manual provides information on Safety and Standards for the MyLab product line.
This manual is organized in the following chapters:
1- Operator Safety.............................................................................................1-1
Installation Requirements .......................................................................................1-1
Electrical Safety......................................................................................................1-1
Environmental Safety..............................................................................................1-2
Moving the Equipment ...........................................................................................1-2
Explosive Hazard ....................................................................................................1-3
Transducers .............................................................................................................1-3
Biocompatibility and Infection Control..................................................................1-4
Repetitive Strain Injury...........................................................................................1-4
Working with Video Display ..................................................................................1-5
Safety Symbols .......................................................................................................1-5
2- Patient Safety.................................................................................................2-1
Electrical Safety......................................................................................................2-1
Electromagnetic Compatibility ...............................................................................2-2
Biocompatibility and Infection Control..................................................................2-2
Ultrasound Safety ...................................................................................................2-3
Glossary and Definition of Terms.........................................................................2-12
3- Devices Standards .........................................................................................3-1
Medical Device Directive .......................................................................................3-1
Medical Electrical Equipment Standard .................................................................3-1
Electromagnetic Compatibility ...............................................................................3-1
Biocompatibility .....................................................................................................3-1
Standards Summary Table ......................................................................................3-2
Acoustic Output ......................................................................................................3-2
Peripherals Standard Requirements ........................................................................3-2
1
M y L a b – S A F E T Y A N D S T A N D A R D
Chapter
1 - Operator Safety
Installation Requirements
The “Getting Started” manual provides detailed instructions to correctly install and
GS connect your specific MyLab model. The same manual also contains all information
on the recommended peripherals that may be connected to the system.
If help is needed, ESAOTE personnel will be glad to provide you with the
necessary assistance to install your system.
Warnings
Incorrect installation of the system may cause operator hazard. Carefully follow the
MyLab “Getting Started” manual instructions for installing your device
Electrical Safety
The equipment label, placed on the rear panel, specifies the device electrical
requirements. Incorrect connections to the main power may compromise the
electrical safety of the system.
Warnings
W A R N I N G S
• Electrical shock hazard. Do not remove the system or the monitor
cover. Refer servicing and internal adjustments to qualified
Observe the
ESAOTE personnel only.
following warnings
for maximum safety
• Always turn the equipment off before cleaning it.
Cautions
C A U T I O N S
• To prevent further damage to your system and the accessories,
turn the unit’s power off if it does not start up correctly.
Observe these
precautions to • If your system incorporates an LCD, note that the screen is fragile
prevent damage to
and must be treated accordingly.
your system
1-1
M y L a b – S A F E T Y A N D S T A N D A R D
Environmental Safety
Information about Reusing/Recycling
This symbol identifies a recyclable component. Depending on the dimensions of a
recyclable component, this symbol and the component’s material are printed on
the component by ESAOTE.
In this system, packing materials are reusable and recyclable; the unit and display
devices casings (plastic) and most of the cart components (plastic) are also
recyclable.
Refer to the MyLab “Getting Started” manual for any additional information on
GS special waste that has to be disposed of according to local regulations.
Exam Waste
Regard any exam waste as potentially infectious and dispose of it accordingly
1-2
M y L a b – S A F E T Y A N D S T A N D A R D
Mobile The MyLab system complies with the EN60601-1: it is not unbalanced by a 10°
Configuration inclination. Observe the following precautions when transporting the system:
• make sure the system is turned off,
• unlock the cart’s wheels prior to moving the system,
• avoid unnecessary shocks to the unit when rolling it over door
jambs or in and out of elevators,
• when transporting the system with the probes attached, make sure
the cables are not dragging on the floor and that the probes are
properly positioned in the cart probe holder,
• always use the handle to move the system. Never push the system
from its sides.
Transportation in Observe the following precautions when transporting the system in a vehicle:
Vehicle
• disconnect any cable or item (probes, ECG cable, …) attached to
the system and place the transducers in their cases,
• a portable model should be packed in the original shipment case
(or other protective devices as available through ESAOTE) during
transportation,
• for mobile systems, make sure the cart wheels are blocked and the
cart secured during transportation.
Explosive Hazard
The equipment is not suitable for use in the presence of a flammable anesthetic
W A R N I N G
mixture with air, oxygen or nitrous oxide. Do not use the system in the presence of
flammable anesthetics. Explosion is a hazard under such conditions.
Transducers
Use only ESAOTE approved transducers with the equipment. The MyLab
GS and AO
“Getting Started” manual lists which probes can be connected to the system.
MyLab “Advanced Operations” explains system related special features, when
applicable.
1-3
M y L a b – S A F E T Y A N D S T A N D A R D
Warnings
W A R N I N G S
• If you drop or strike a probe against another object, do not use it
Damage caused by until an electrical leakage current measurement test has
dropping a probe,
striking it against demonstrated that the electrical safety has not been compromised.
another object,
pinching, kinking or
• Do not immerse the entire transducer in liquid to clean it. The
twisting the cable are transducer is not watertight and immersion may compromise the
not covered under electrical safety features of the probe.
warranty.
Cautions
C A U T I O N S
• Never expose the probes to gas, heat or liquid sterilization
procedures. These methods can permanently damage the probe.
Observe these
precautions to • Do not connect or disconnect an active probe during live
prevent damage to
scanning; the system must be in freeze mode or turned off to
connect or disconnect a probe.
your system
• Carefully follow the “Probes and Consumables” manual
instructions to clean or disinfect a probe.
Pike I, Russo A., Berkowitz J et al. “ the prevalence of musculoskeletal disorders among Diagnostic
Medical Sonographers”, Journal of Diagnostic Medical Sonography 13, p. 219-227, 1997
1-4
M y L a b – S A F E T Y A N D S T A N D A R D
Safety Symbols
The MyLab device uses the EN60601-1 safety symbols for medical electronic
devices to classify a connection or to warn of any potential hazards.
On (power)
Off (power)
Equipotentiality
High Voltage
2 See for example OSHA 3092 “Working safely with video terminals display” 1997
1-5
M y L a b – S A F E T Y A N D S T A N D A R D
1-6
2
M y L a b – S A F E T Y A N D S T A N D A R D
Chapter
2 - Patient Safety
Electrical Safety
Warnings
2-1
M y L a b – S A F E T Y A N D S T A N D A R D
Electromagnetic Compatibility
Ultrasound systems require special precautions regarding EMC and must be
installed and put into service according to the provided information.
Sensitivity to Ultrasound units are designed to generate and receive radiofrequency (RF) energy
interference is more and are, therefore, susceptible to other RF sources. As an example, other medical
noticeable in Doppler
modes.
devices, information technology products or TV/radio transmitters may cause
interference with the ultrasound system.
Warnings
W A R N I N G S
• Portable and mobile RF communication equipment may cause
interference with the ultrasound system. Do not use these devices in
GS the vicinity of ultrasound equipment.
The “Getting
Started” manual
provides the table for
• Use of accessories and cables other than those specified in the MyLab
equipment distance “Getting Started” manual may result in increased emission or
requirements. decreased immunity of the system.
If an ultrasound system causes interference (This can be identified by turning the
system off and on) with other devices, the user could try to solve the problem by:
2-2
M y L a b – S A F E T Y A N D S T A N D A R D
Note
The transducer protective covers used during the patient exam are usually
W A R N I N G
composed of latex. Carefully read the protective cover package labeling to verify
the material used. Be certain to identify latex sensitive patients prior to the exam.
Serious allergic reactions to latex have been reported and the user should be ready
to react accordingly.
Ultrasound Safety
Introduction
ESAOTE has adopted the more recent requirements and recommendations
GS established by the USA Food and Drug Administration and by the American
MyLab “Getting
Started” manual Institute of Medicine and Biology. MyLab is equipped with the Acoustic Output
provides data about Display feature to provide the user with real-time, on-line information on the
the acoustic power actual power of the system. The following sections describe the rationale of this
levels. methodology. ESAOTE recommends the use of the ALARA principle (see
below), which is extensively covered in this manual.
Clinical Safety
Refer to the glossary In the USA, in more than three decades of use, there has been no report of injury
at the end of this to patients or operators from medical ultrasound equipment.
chapter for specific
terms.
American Institute for Ultrasound in Medicine (AIUM)
Statement on Clinical Safety: October 1982, Revised March
1983, October 1983 and March 1997.
Diagnostic ultrasound has been in use for over 25 years. Given its
known benefits and recognized efficacy for medical diagnosis,
including use during human pregnancy, the American Institute of
Ultrasound in Medicine herein addresses the clinical safety of such
use:
2-3
M y L a b – S A F E T Y A N D S T A N D A R D
The ALARA (As Low As Reasonably Achievable) principle is the guideline for
prudent use: during an exam, the user should use for the shortest duration the least
amount of acoustic output to obtain the necessary clinical information for
diagnostic purposes.
Ultrasound Bioeffects
Although diagnostic ultrasound has an excellent history of safety, it has been
known for a long time that ultrasound, at certain levels, can alter biological systems.
The AIUM Bioeffects Committee describes two fundamental mechanisms by
which ultrasound may induce biological effects: non-thermal or mechanical
mechanisms1 and thermal effects.
1American Institute of Ultrasound in Medicine Bioeffects Committee, Bioeffects Considerations for the
Safety of Diagnostic Ultrasound, J. Ultrasound Med., 1988, 7 Suppl.
2-4
M y L a b – S A F E T Y A N D S T A N D A R D
For systems with an output display, the FDA currently regulates only the
maximum output. MyLab system has been designed to automatically default the
proper range of intensity levels for a particular application. However, within the
limits, the user may override the application specific limits, if clinically required.
The user is responsible for being aware of the output level that is being used. The
MyLab real-time output display provides the user with relative information about
the intensity level.
2Also known as the preamendments limits, those values were established on the basis of acoustic output
of equipment on the market before 1976.
2-5
M y L a b – S A F E T Y A N D S T A N D A R D
bioeffect is actually occurring: the index is not intended to give an "alarm" but to
use it to implement the ALARA principle.
Note
2-6
M y L a b – S A F E T Y A N D S T A N D A R D
Initial data are derived from laboratory measurements based on the AIUM
standard. Then the indices are calculated beginning from these measurements
according to the AIUM/NEMA "Standard for Real-Time Display of Thermal and
Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment"
publication. Many of the assumptions used for measurements and calculation are
conservative in nature. The measured water tank values are derated using the
conservative attenuation coefficient established by the standard (0.3 dB/cm/MHz).
Over-estimation of actual in-situ exposures is thus part of the calculation process.
INDICES
Accuracy: ±14% for the MI, ±30% for the TI A number of factors influence the
estimation of the accuracy of the displayed indices, the most significant ones being
ACCURACY
the variability between probes and the laboratory measurements accuracy
(hydrophone, operator, algorithms, etc.) itself, while variability of the system pulser
and efficiency is a minor contributor.
The accuracy estimate, based on the variability range of probes and systems, and
on the inherent modeling and measurements errors, is 14% for the MI and 30%
for TI indices; this accuracy estimate does not consider errors in/or caused by
measuring with the AIUM standard.
2-7
M y L a b – S A F E T Y A N D S T A N D A R D
3. controls, which do not affect the intensity, such as the gains and the
processing curves.
Controls Which Directly Affect the Intensity
This category includes two system controls:
DIRECT
CONTROLS
• the application selection, which establishes the appropriate range of
intensities (see maximum output section); the application also
ο the Application establishes the indices to be displayed;
ο the POWER
• the POWER control, which allows an increase or decrease in the
output intensity within the range of the selected application. This
parameter will affect both the MI and the TI values.
Controls Which Indirectly Affect the Intensity
This category includes controls, which change several aspects of the transmitted
INDIRECT
ultrasonic field rather than the intensity. Intensity is affected because of the field
CONTROLS
variations. Each mode has its own pulse repetition frequency (PRF) and intensity
ο PRF level; moreover, for each mode, a number of parameters will indirectly affect the
ο Focal Point
transmitted field.
ο Frequency
ο CFM Process
ο Sample Volume
2-8
M y L a b – S A F E T Y A N D S T A N D A R D
Note
2D The MI may increase whenever the PRF is decreased, i.e. when the field of view is
increased.
MyLab allows the user to set the transmit focal point which will affect both indices
by varying the beam profile. Generally, higher MI's and TI's will occur with closer
focal points. If more than one transmit focal point is activated, MI and TI values
will each correspond to the zone with the largest value. In addition, all system
probes can image at two frequencies; both indices are usually different, depending
on the probe bandwidth.
TEI The same controls described for 2D affect the acoustic output. Because the tissue
response is a non-linear phenomenon, this modality usually requires higher
acoustic outputs than conventional imaging. While using this mode, the MI is
your primary concern; a deeper transmit focal point helps to keep the MI value as
low as possible.
M-Mode In M-Mode, the transmitted field is only affected by the transmit focal point and
the frequency. If M-Mode is displayed with 2D and the 2D is updated, the system
may show the latter mode MI (and TI if available) if higher.
2D-CFM The MI is primarily dependent on 2D settings, i.e. the depth (which will determine
the 2D and color PRF) and the transmit focal point. The MI may also be increased
by a decrease in the color PRF.
The TI may be increased by increasing the color CFM. Increasing the color frame
rate may increase the TI while decreasing the MI. Finally, probes can provide color
at two frequencies; the outcome in terms of transmitted field is marginal and
largely unpredictable.
TVM This mode optimizes CFM settings in order to image the movement of tissue, thus
the same controls described for 2D-CFM affect the acoustic outputs.
Pulsed Wave In PW, the sample volume depth automatically sets the Doppler PRF and the focal
Doppler point. Deeper sample volumes will cause lower PRF; the MI may, however, not
increase since the focal point is far, while the TI is generally reduced. The TI may,
however, change if the sample volume size is varied. This factor accounts generally
for a MI modification.
Finally, most probes provide Doppler at two frequencies; the outcome in terms of
transmitted field is marginal and largely unpredictable.
2-9
M y L a b – S A F E T Y A N D S T A N D A R D
Continuous Wave In CW, the only "variable" factor is the Doppler frequency. As stated before, most
Doppler probes provide Doppler at two frequencies; the outcome in terms of transmitted
field is marginal and largely unpredictable. The user can vary the spectral velocity
range; this does NOT, however, change the system’s PRF.
Note
This section does not cover the patient and technique factors, which may influence
the indices such as the patient body size, the tissue perfusion characteristics, the
presence or the absence of fluid, etc.
ALARA Guidelines • Select the appropriate Application when you enter the patient data.
• Depending on the patient characteristics and the type of exam (see
Intended Use Section) select the appropriate probe and frequency.
Use the system capabilities to preset the MyLab system to default each mode
according to your needs or specific applications; this will reduce the need for real-
time interactions and help to obtain useful images quickly thus reducing ultrasound
exposure.
GS • Start scanning with a low output level and optimize the focusing, the
See the “Getting gains and all other system adjustments; if this is not adequate for
Started” manual for diagnostic purposes, then increase the output level. In cardiac studies,
your system controls. use Tissue Enhancement Imaging if acoustic noise is affecting the
images’ readability.
• Use the output display feature to guide your settings; remember that
the indices do not consider TIME exposure: the higher your indices,
the shorter the patient exposure should be.
Which Index When
In cardiac, vascular, In cardiac, vascular and general purpose (abdominal, small parts,
abdominal and small musculoskeletal) exams, the system displays the TIS in addition to the MI. In
parts examinations,
MI is the primary
imaging and CFM modes, the primary concern is in keeping the "cavitation"
concern in imaging predictor as low as possible. You can minimize the MI by reducing the power to
modes, while the TIS the lowest possible level, and adjusting the TGC and general gain controls. Use the
is the principle index transmit focal point to enhance resolution and sensitivity in the area of interest: this
in Doppler.
2-10
M y L a b – S A F E T Y A N D S T A N D A R D
may increase the MI, but because of the enhanced sensitivity, you may be able to
reduce the transmit power, thus reducing the MI. Decreasing the imaging depth as
low as possible may allow the system to increase the PRF and thus reduce the MI.
In Doppler modes, if you are working with a 2D + Doppler display, the MI will
show the 2D value (because it is higher than the Doppler one) and the Doppler
TIS; the latter parameter should be your primary concern: the MI value reflects the
energy to which the patient is exposed only for a minimal time, i.e. between every
sweep. You may want however to remember that whenever varying the Doppler
speed: increasing the speed will cause the 2D to be refreshed more often. You may
eventually freeze the 2D or switch to a full screen mode; however, this will
probably increase the time to actually find the desired signal, and therefore the
exposure time.
In OB, the TIB In OB exams, this system displays both the MI and the TIB in imaging and CFM
should be considered modes. While the MI will remain your primary concern in those modes, you
when scanning a
second or third
should also consider the TIB in imaging a second or third trimester fetus as a
trimester fetus, while conservative estimate of the actual temperature rise. In PW Doppler, the latter
the TIS is more value is the primary parameter to consider for second or third trimesters
reliable for earlier pregnancies while the TIS is a more reliable indicator for earlier exams. The general
exams. guidelines already expressed for the previous exams remain valid.
The TIB is a better For Neonatal Head studies, the MI and the TIB may be significant in imaging
predictor during and CFM modes, while the MI and both TIS and TIB are displayed for Doppler
neonatal head
studies, while the
modes. Because of the chance of focusing near the base of the skull, the TIB
TIC is more should be conservatively considered the ideal thermal index. As usual the MI is the
significant in adult primary concern in imaging modes, and the TIB in Doppler. The general
transcranial studies. guidelines expressed above are valid. In Adult Cephalic, because of the skull, the
TIC is considered the most significant index for this application. The general
guidelines expressed above are valid.
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The intensity When determining the possible effects of the ultrasound beam on tissue, the
measurements made intensity encountered at the tissue site must be calculated. Because of attenuation
in water in the
laboratory must be
of the beam within the body, the intensity at the tissue site ("in situ") may be 10 to
derated to reflect the 100 times less than if it was measured at the same location in water. The amount of
effects of attenuation. attenuation from experience by an ultrasound beam as it travels through the body
tissue is determined by three factors:
Id = Iw exp (-0.23 a f z )
• Id is the estimated "in situ" intensity at the tissue site
• Iw is the intensity measured in water at a distance "z", measured in cm
• a is the attenuation coefficient7 expressed in dB/cm/MHz
• f = acoustic frequency in MHz of the ultrasound beam
Definition of Terms
Ispta The Spatial Peak Time Average Intensity is an ultrasound intensity averaged over
time at the point in the acoustic field where the pulse average intensity is at
maximum.
Isppa The Spatial Peak Pulse Average Intensity is an ultrasound intensity averaged over
the pulse transmission time at a point in the acoustic field where the pulse average
intensity is at maximum.
Imax The Maximum Intensity is an average intensity during the half-cycle with the
greatest amplitude during the pulse.
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Mechanical Index The Mechanical Index is defined as the peak rarefactional pressure in MPa (derated
by a tissue attenuation coefficient of 0.3 dB/cm/MHz) divided by the square root
of the probe central frequency in MHz.
Thermal Index The Thermal Index is the ratio between the acoustic power and the power required
to raise tissue temperature by 1°C, estimated on thermal models.
Peak Rarefactional The peak rarefactional pressure (pr in MPa) is the temporal peak rarefactional
Pressure pressure amplitude at a specified point.
Pulse Intensity The Pulse Intensity Integral (PII) is the time integral of instantaneous velocity for
Integral any specific point and for any specific pulse, integrated over the time in which the
envelope of acoustic pressure or the envelope of hydrophone signal for the specific
pulse is non-zero. It is equal to the energy fluence per pulse.
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Indices Equations
Parameter Equation
Soft Tissue at Surface W01
TIS(scanned8) 210
TIB (scanned6)
fc
2
Large Aperture (Aaprt> 1 cm )
TIS (unscanned9) [ (
max min W.3 ( z ); I TA.3 ( z ) x1cm 2
z > zbp
)]
210
fc
2
Small Aperture (Aaprt≤ 1 cm ) W0
TIS (unscanned7) 210
fc
Bone at Focus TIB ⎧⎪ W ( z ) I ( z ) w ( z ) ⎫⎪
(unscanned7) min ⎨ .3 B.3 TA.3 B.3 ; .3 B.3 ⎬
⎪⎩ 50 4.4 ⎪⎭
where zB.3 is the depth that maximizes W.3(z)ITA.3(z), or,
equivalently, the depth of ISPTAB.3.
Bone at Surface TIC W0
40 Deq
Mechanical Index (MI) pr . 3( z sp )
fc
where pr.3(zsp) is the peak rarefactional pressure (in
MPa) derated by 0.3 dBcm-1MHz-1 to the point on the
beam axis zsp where pulse intensity integral (PII.3) is
maximum, and fc is the center frequency (in MHz).
8The scanned mode (or autoscanning) is the electronic or mechanical steering of successive ultrasonic
pulses or series of pulses, through at least two dimensions.
9The unscanned mode (or nonautoscanning) is the emission of ultrasonic pulses in a single direction,
where scanning in more than one direction would require moving the transducer assembly manually.
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Symbol Definition
2
Aaprt (cm ) Active aperture area
deq(z) (cm) Equivalent beam diameter
4W.3 ( z )
πI TA.3 ( z )
Deq (cm) Equivalent aperture diameter
4 Aaprt
π
fc (MHz) Center frequency.
ISPTAB.3 (mW/cm2) Equivalent to the spatial peak temporal average derated
(0.6 dBcm-1MHz-1) intensity
ITA.3 (z) (mW/cm2) Temporal average intensity derated to depth z
W0 (mW) Time average acoustic power at source
W01 (mW) Time average acoustic power at the source emitted from
the central centimeter of the active aperture
W.3 (z) (mW) Time average acoustic power derated to depth z
W Acoustic power per unit linear length (for example of a
(mW/cm) linear array)
X
z (cm) Depth from the surface along the beam axis
zbp (cm) Break point depth (minimum depth for intensity
measurements in the TIS(unscanned) models)
zbp = 1.5Deq
zB.3 (cm) Depth of the maximum temperature rise in the bone at
focus model
pr.3(zsp) Peak rarefactional pressure (in MPa) derated by 0.3
dBcm-1MHz-1 to the point on the beam axis zsp where
pulse intensity integral (PII.3) is maximum
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Chapter
3 - Devices Standards
U.S. Federal Law restricts these devices to sale, distribution and use
by or on the order of a physician.
These devices also comply with the EN 60601-2-37 (IEC 60601-2-37) “Particular
requirements for the safety of ultrasonic medical diagnostic and monitoring
equipment”.
Electromagnetic Compatibility
Each MyLab model complies with the EN60601-1-2 (Electromagnetic
GS Compatibility). Refer to the MyLab “Getting Started” manual for the
electromagnetic emissions classification of the devices and electromagnetic
immunity compliance levels.
Biocompatibility
The probe and electrode material that is in contact with patients, complies with the
applicable requirements of EN ISO 10993-1, according to their intended use. No
negative reactions to these materials have been reported.
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Acoustic Output
MyLab acoustic output complies with the requirements of FDA Track 3 guidance.
Safety
Electromagnetic Compatibility
Your peripheral device must:
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